Identity
- Trade Name
- Faxitron CT FDA UDI
- Generic Name
- Tissue specimen x-ray system IVD FDA UDI
- Device Name
- Cabinet x-ray device used to generate x-ray of specimens from various anatomical regions FDA UDI
- Model / Reference
- VISION CT FDA UDI
- Description
- Cabinet x-ray device used to generate x-ray of specimens from various anatomical regions FDA UDI
Identifiers
- Catalog Number
- FAX-019 FDA UDI
- Primary DI / UDI-DI
- 15420045514911 FDA UDI
- FDA Product Code
- MWP FDA UDI
- GMDN Term
- Tissue specimen x-ray system IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Faxitron CT by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hologic, Inc.
Sources (1)
- FDA UDI c0e1d56f-ed90-4762-8bbf-6be26cd16131 37 fields · synced May 30, 2026