Identity
- Trade Name
- OPS™ FHA FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Model / Reference
- 1205-0001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09351327000374 FDA UDI
- 510(k) Number
- K190834 FDA UDI
- FDA Product Code
- PLW FDA UDILWJ FDA UDIMEH FDA UDILZO FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3360 FDA UDI888.3353 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
Ops™ Fha by Optimized Ortho Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Optimized Ortho Pty Ltd
Sources (1)
- FDA UDI 72de73fa-c937-484c-9c25-92bf8d9d7215 33 fields · synced Jun 1, 2026