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Faxitron

FDA UDI

Class II (US FDA UDI)

by Faxitron Bioptics, LLC

Identity

Trade Name
Faxitron FDA UDI
Generic Name
Stationary specimen x-ray system, digital FDA UDI
Device Name
Stationary Cabinet x-ray system with 15x15 cm imager used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions. FDA UDI
Model / Reference
VisionCT 15x15 FDA UDI
Description
Stationary Cabinet x-ray system with 15x15 cm imager used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions. FDA UDI

Identifiers

Primary DI / UDI-DI
00857069006227 FDA UDI
510(k) Number
K173309 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

Similar devices

Also classified as Stationary specimen x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Faxitron Bioptics, LLC

Sources (1)

  • FDA UDI 8211e7cd-08d5-438c-99b7-ada197dde365 34 fields · synced May 30, 2026