Identity
- Trade Name
- Signature ONE Software Package FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- v. 1.2 FDA UDI
- Model / Reference
- 302.4018 FDA UDI
- Description
- v. 1.2 FDA UDI
Identifiers
- Catalog Number
- 302.4018 FDA UDI
- Primary DI / UDI-DI
- 00889024647046 FDA UDI
- FDA Product Code
- QHE FDA UDIKWS FDA UDIKWT FDA UDIMBF FDA UDIPHX FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3650 FDA UDI888.3670 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
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
Signature ONE Software Package by Orthosoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190595 also covers:
- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left — Orthosoft Inc
- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Right — Orthosoft Inc
- Comprehensive® Reverse Shoulder Mini Guide and Bone Model Left — Orthosoft Inc
- Comprehensive® Reverse Shoulder Mini Guide and Bone Model Right — Orthosoft Inc
- Comprehensive® Total Shoulder Guide and Bone Model Left — Orthosoft Inc
- Comprehensive® Total Shoulder Guide and Bone Model Right — Orthosoft Inc
- Shoulder Bone Model Only 2.5mm Pin — Orthosoft Inc
- Shoulder Bone Model Only 3.2mm Pin — Orthosoft Inc
- Shoulder Pure Planning — Orthosoft Inc
- Signature ONE Software Package — Orthosoft Inc
- Signature ONE Software Package — Orthosoft Inc
- TMR+™ Shoulder Guide and Bone Model Left — Orthosoft Inc
K192074 also covers:
K200615 also covers:
K212560 also covers:
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
- Orthosoft Inc
Sources (1)
- FDA UDI 44b95eb4-48b9-49e8-99b2-84936bd5b313 35 fields · synced May 30, 2026