Identity
- Trade Name
- Optimized Positioning System (OPS) Plan FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- OPS Plan V.2.0 FDA UDI
- Model / Reference
- 1250-1300 FDA UDI
- Description
- OPS Plan V.2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09351327000091 FDA UDI
- 510(k) Number
- K183038 FDA UDI
- FDA Product Code
- MEH FDA UDILZO FDA UDILLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI892.2050 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
Yes
FDA UDI
Category: Radiology DICOM image processing application software
Optimized Positioning System (OPS) Plan 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 e45777b7-5e13-4bb1-a755-11f123dad3fb 34 fields · synced Jun 8, 2026