Identity
- Trade Name
- Faxitron FDA UDI
- Generic Name
- Stationary specimen x-ray system, digital FDA UDI
- Device Name
- Stationary digital specimen x-ray system with 6x15 cm imager intended for the verification of harvested biopsy specimens. The VersaVision x-ray cabinet is designed as a digital system, but can also be used with film. FDA UDI
- Model / Reference
- VersaVision 6x15 FDA UDI
- Description
- Stationary digital specimen x-ray system with 6x15 cm imager intended for the verification of harvested biopsy specimens. The VersaVision x-ray cabinet is designed as a digital system, but can also be used with film. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857069006203 FDA UDI
- 510(k) Number
- K170786 FDA UDI
- FDA Product Code
- MWP FDA UDI
- GMDN Term
- Stationary specimen x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary specimen x-ray system, digital
Faxitron by Faxitron Bioptics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Faxitron — Faxitron Bioptics, LLC · Class II
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Cleared under the same submission
K170786 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
- Faxitron Bioptics, LLC
Sources (1)
- FDA UDI 8b8009cf-fbe6-4aef-8d7b-d2ef6e576b1c 34 fields · synced May 30, 2026