Identity
- Trade Name
- interWORKS FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Model / Reference
- Version 8.7.0.21176 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850054590107 FDA UDI
- FDA Product Code
- LMD FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.2020 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
Yes
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
No
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 softwareRadiology information system
interWORKS by Avreo, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiology information system.
- ENDOPRO IQ — PENTAX of America, Inc. · Class I
- ENDOPRO IQ — PENTAX of America, Inc. · Class I
- ENDOPRO IQ — PENTAX of America, Inc. · Class I
- ENDOPRO IQ — PENTAX of America, Inc. · Class I
- ENDOPRO IQ — PENTAX of America, Inc. · Class I
- ENDOPRO IQ — PENTAX of America, Inc. · Class I
- Orpheus VOD CSS — ORPHEUS MEDICAL LTD · Class II
- ENDOPRO IQ — PENTAX of America, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avreo, Inc.
Sources (1)
- FDA UDI a71abac6-1d1e-4207-954a-899fd8b75097 32 fields · synced Jun 8, 2026