Identity
- Trade Name
- Faxitron FDA UDI
- Generic Name
- Tissue specimen x-ray system IVD FDA UDI
- Device Name
- Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excisions. FDA UDI
- Model / Reference
- BioVision + FDA UDI
- Description
- Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excisions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857069006210 FDA UDI
- 510(k) Number
- K153583 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
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Tissue specimen x-ray system IVD
Faxitron by Faxitron Bioptics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153583 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 1015f796-89f1-48c9-9e42-37ea794e7e61 34 fields · synced May 30, 2026