Identity
- Trade Name
- FractureDetect (FX) FDA UDI
- Generic Name
- X-ray image interpretive software FDA UDI
- Device Name
- FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only. FDA UDI
- Model / Reference
- 1.0.0 FDA UDI
- Description
- FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852491008016 FDA UDI
- 510(k) Number
- K193417 FDA UDI
- FDA Product Code
- QBS FDA UDI
- GMDN Term
- X-ray image interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2090 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
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: X-ray image interpretive software
FractureDetect (FX) by Imagen Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as X-ray image interpretive software.
- Annalise Triage — Annalise-Ai Pty , Ltd. · Class II
- e-CTP — BRAINOMIX LIMITED · Class II
- Imbio RV/LV — Imbio, LLC · Class II
- InferRead CT Stroke.AI — Infervision US Inc · Class II
- Imbio RV/LV — Imbio, LLC · Class II
- Triage LVO — BRAINOMIX LIMITED · Class II
- Triage Stroke — BRAINOMIX LIMITED · Class II
- InferRead Lung CT.AI 2.1.2.1 — Infervision US 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Imagen Technologies, Inc.
Sources (1)
- FDA UDI 9b8bff47-11fb-45ef-9409-8b76e24a9d5a 34 fields · synced May 29, 2026