SKYIQ Archive Manager 1.1.0HSA: Not a Medical Device

Lightweight DICOM Archive for Clinics, Imaging Centres and Hospitals

Store, search and manage CT, MRI, X-ray and ultrasound studies with a compact imaging archive that gives your organisation full control over imaging data β€” without the cost and complexity of an enterprise PACS or VNA.

Best suited for: specialty clinics, imaging centres, community hospitals and healthcare providers across Southeast Asia that need secure on-premise DICOM storage, fast retrieval, audit trails and backup-ready architecture.

SG βœ“MY TH ID PH VN
SKYIQ Archive Manager β€” DICOM study list interface
DICOM Store SCP/SCUMetadata SearchRole-Based Access

Singapore HSA Regulatory Determination

Confirmed
Health Sciences Authority (HSA), Singapore
"Based on the information provided, the SKYIQ ARCHIVE MANAGER 1.1.0, a non-diagnostic standalone software intended to be used for storage purposes only, does not fall under the definition of a medical device."
Reference: HSA REF No. HSA24697115460 Β· Response to enquiry dated 22/07/2025

This determination confirms that SKYIQ Archive Manager is not subject to Singapore's medical device registration requirements under the Health Products Act. Healthcare providers can procure and deploy the system without the regulatory burden associated with medical device software.

Radiologist reviewing CT and MRI imaging studies at a workstation

Who It Is For

Not every institution needs an enterprise archive

Enterprise PACS and VNA systems are designed for large hospital groups with complex multi-department workflows, multi-site networks and dedicated radiology IT teams. For smaller institutions, they often represent over-investment in infrastructure that exceeds actual operational needs.

SKYIQ Archive Manager is designed for healthcare providers that need a compact, secure and manageable DICOM archive β€” as a primary archive, secondary archive, backup node or Mini PACS storage layer β€” without the procurement complexity and ongoing overhead of enterprise systems.

Specialty clinics
Imaging centres
Community hospitals
Polyclinics
Dental & oral surgery
Orthopaedic centres
Oncology centres
Private hospitals

Core Capabilities

Store, search, control and retain imaging studies

SKYIQ Archive Manager provides the core capabilities needed to manage DICOM imaging data throughout its lifecycle β€” from initial storage through retrieval, access governance and long-term retention.

Multi-Modality DICOM Storage

Store imaging studies from CT, MRI, X-ray, ultrasound and other DICOM-compliant modalities in one controlled archive.

DICOM Store SCP/SCU

Metadata-Driven Study Retrieval

Find prior studies faster using patient ID, modality, study date and accession number metadata. No manual file navigation.

DICOM Q/R SCP

Web-Based HTML5 Viewer

Allow authorised users to review studies through a standard browser without installing workstation software.

Zero-footprint viewer

Role-Based Access Control

Limit access by user role, department or operational responsibility to reduce unnecessary exposure of imaging data.

LDAP / Active Directory

Full Audit Trails

Record access, viewing, download and change activities systematically to support internal accountability and incident review.

Immutable activity log

Image Lifecycle Management

Apply retention and archival rules so imaging data can be managed over its full lifecycle according to institutional policy.

Rule-based ILM engine

Technical Architecture

DICOM-native architecture that fits existing workflows

SKYIQ Archive Manager is built on standard DICOM protocols and integrates with existing modalities, PACS systems and clinical workflows without requiring proprietary connectors or middleware.

DICOM Services
DICOM Store SCP/SCUDICOM Query/Retrieve SCPDICOM Worklist (optional)
Security
AES-256 encryption for stored dataTLS for data in transitRole-based access control
Identity Management
LDAP integrationActive Directory supportLocal user management
Compliance Standards
HIPAA security principlesAudit trail (access, edit, download)Configurable data retention
Hospital IT administrator reviewing medical imaging data
Integration note: SKYIQ Archive Manager can function as a primary archive, a secondary backup archive, or a Mini PACS storage layer alongside an existing PACS. No replacement of existing systems is required.

Deployment & Operations

On-premise deployment with backup-ready options

SKYIQ Archive Manager is deployed within the healthcare provider's own IT environment, keeping imaging data under institutional control. Backup, high availability and disaster recovery configurations are available to match operational requirements.

On-Premise Deployment

Keep imaging data within the clinic or hospital network boundary when cloud deployment is not preferred or permitted.

Disaster Recovery Ready

Configure backup strategies with RPO and RTO aligned to organisational policy. Supports multiple backup destinations.

High Availability Architecture

Supports clustering with load balancing, active failover and database replication for continuous operations.

Storage Scalability

Scales from a single-site clinic archive to a multi-node deployment as imaging volume grows over time.

Security & Governance

Built for controlled imaging data environments

Healthcare imaging data requires more than storage capacity. It requires clear access rules, traceable activity, secure retention and operational continuity. SKYIQ Archive Manager is designed to support these governance needs.

Governance ConcernArchive Manager CapabilityWhat It Means
Access minimisationRole-based access controlAccess configured by role and operational responsibility.
TraceabilityAudit trailsUser access, edits and downloads systematically recorded.
Data protectionAES-256 encryptionStored imaging data protected with AES-256 encryption.
Data retentionLifecycle managementRetention and archival policies configurable by institution.
Local data controlOn-premise deploymentData remains within the healthcare provider's IT environment.
Business continuityBackup and HABackup, failover and replication options support resilience.
Compliance note:: SKYIQ Archive Manager is designed to support healthcare providers' imaging data governance needs. It does not constitute legal compliance advice. Institutions should assess their specific obligations under applicable regulations including Singapore's PDPA, Health Information Act and relevant cybersecurity guidelines.

Comparison

Archive Manager vs Enterprise PACS vs VNA vs NAS

Understanding where SKYIQ Archive Manager fits relative to other imaging storage options helps institutions make the right procurement decision.

CriterionSKYIQ Archive ManagerEnterprise PACSVNANAS / File Server
Target institutionClinics, imaging centres, small–mid hospitalsLarge hospital groups, multi-site networksMulti-vendor, multi-specialty long-term archiveNon-clinical file backup only
DICOM servicesStore SCP/SCU, Q/R SCPFull DICOM suiteFull DICOM + XDS/IHENone
Deployment complexityLow β€” single-site on-premiseHigh β€” multi-phase implementationVery high β€” governance framework requiredVery low β€” no imaging workflow
Regulatory audit trailYes β€” full user activity logYesYesNo
Role-based accessYes β€” LDAP/AD integrationYesYesNo
Typical cost modelCompact β€” fits clinic/centre budgetHigh CAPEX + ongoing supportHigh CAPEX + governance overheadLow β€” but no imaging value
HSA classification (SG)Not a medical device (REF: HSA24697115460)Varies by productVaries by productNot applicable

Implementation Process

A structured path from assessment to go-live

SKYIQ follows a defined implementation process to ensure the archive is correctly sized, configured and integrated within your institution's IT environment.

01

Deployment Fit Assessment

We review your institution's modality types, study volume, network architecture and compliance requirements to confirm fit.

02

Technical Architecture Brief

A detailed architecture document is prepared covering server specifications, storage sizing, network topology and integration points.

03

Installation & Configuration

SKYIQ engineers install and configure the archive on-premise, including DICOM routing, LDAP/AD integration and lifecycle policies.

04

Data Migration (if applicable)

Existing imaging studies can be migrated from legacy systems or storage media with accession number and metadata preservation.

05

Training & Handover

Administrator and end-user training is conducted. Full documentation and runbooks are provided for your IT team.

06

Ongoing Support

SKYIQ provides post-deployment support with defined response SLAs. System health monitoring and update management available.

Frequently Asked Questions

Common questions from procurement and IT teams

No. Singapore's Health Sciences Authority (HSA) has confirmed that SKYIQ Archive Manager 1.1.0, as a non-diagnostic standalone software intended for storage purposes only, does not fall under the definition of a medical device. Reference: HSA REF No. HSA24697115460.

SKYIQ Archive Manager supports all DICOM-compliant modalities including CT, MRI, X-ray (DX/CR), ultrasound, mammography, nuclear medicine and fluoroscopy. Any device that outputs standard DICOM files can route studies to the archive.

SKYIQ Archive Manager is designed as a compact archive, backup node or Mini PACS storage layer β€” not as a full replacement for enterprise PACS in large multi-department hospital networks. It is best suited for institutions that need controlled DICOM storage without the cost and complexity of enterprise PACS or VNA.

The primary deployment model is on-premise, within the institution's own IT environment. Hybrid configurations with cloud backup destinations are supported. Full cloud-only deployment is available on request for specific use cases.

SKYIQ Archive Manager supports DICOM Store SCP/SCU and DICOM Query/Retrieve SCP. Modalities and existing PACS systems can route studies directly to the archive using standard DICOM protocols. No proprietary connectors are required.

The archive supports AES-256 encryption for stored data, role-based access control with LDAP/Active Directory integration, full audit trails for all user activities, and configurable data retention policies. On-premise deployment keeps data within the institution's controlled network boundary.

SKYIQ Archive Manager is available across Southeast Asia including Singapore, Malaysia, Thailand, Indonesia, the Philippines and Vietnam. SKYIQ works with local implementation partners in each market.

A standard single-site deployment typically takes 2–4 weeks from assessment to go-live, depending on infrastructure readiness and data migration scope. SKYIQ provides a detailed project timeline during the assessment phase.

Get in Touch

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