Identity
- Trade Name
- Faxitron OR FDA UDI
- Generic Name
- Tissue specimen x-ray system IVD FDA UDI
- Model / Reference
- BioVision 10x15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857069006265 FDA UDI
- 510(k) Number
- K091558 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
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: Tissue specimen x-ray system IVD
Faxitron OR by Faxitron Bioptics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue specimen x-ray system IVD.
- Myrian® 2.12 : XP-Cardiac CT — INTRASENSE · Class IIa
- coDiagnostiX — Dental Wings GmbH · Class IIa
- Myrian® 2.13 : XP-Liver — INTRASENSE · Class IIa
- Myrian® 2.13 : XM-CT — INTRASENSE · Class IIa
- Stacja przeglądowa cyfrowych i analogowych obrazów Rtg typu DiCO 2M/2B — ULTRA-VIOL Pietras Purgał Wójcik Spółka Jawna · Class I
- Clarix Imaging Corps — Clarix Imaging · Class II
- Myrian® 2.12 : XP-AbdoFat — INTRASENSE · Class IIa
- NEGATOSKOP(TRIPLE) — TUR-MED HASTANE MALZ. SAN. TIC. LTD. ŞTI. · Class I
Cleared under the same submission
K091558 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Faxitron Bioptics, LLC
Sources (1)
- FDA UDI 1c1e3229-44b7-41f5-9232-e95c69e26454 33 fields · synced May 30, 2026