Identity
- Trade Name
- PACSgear Enterprise Server FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos, and HL7 messages. It also handles user accounts, security, client configuration, and the flow of data between modalities and destination DICOM systems. PACSgear FDA UDI
- Model / Reference
- 5.1.X FDA UDI
- Description
- PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos, and HL7 messages. It also handles user accounts, security, client configuration, and the flow of data between modalities and destination DICOM systems. PACSgear FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850677007396 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiological PACS software
PACSgear Enterprise Server by Hyland Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological PACS software.
- AVIEW — CORELINE SOFT CO., LTD. · Class II
- ThinkingNet — THINKING SYSTEMS CORP. · Class II
- IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
- EAGLESOFT — PATTERSON TECHNOLOGY CENTER · Class II
- QuantX — Qlarity Imaging · Class II
- interWORKS — Avreo, Inc. · Class I
- NovaPACS — Novarad Corporation · Class II
- OrthoNext™ Platform System Software — Orthofix, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hyland Llc
Sources (1)
- FDA UDI 1f6e15da-abb8-4cd8-b390-6ebe478b9582 33 fields · synced May 30, 2026