Cabinet, X-ray System

Product Code: MWP

Radiology Cabinet X-Ray Systems / Medical

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Cabinet X-ray Systems. [1020.40]

Code of Federal Regulations: 892.1680


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as MWP

5397Cabinet, X-ray SystemStationary X-ray System.

Total Product Life Cycle (TPLC) Devices

5397Cabinet, X-ray SystemStationary X-ray System.

Pre-market Notifications for MWP

K213691Solas ORCirdan Imaging Ltd
K200756Kubtec Mozart SupraKUB Technologies, Inc.
K193317CoreLite X-Ray Specimen CabinetCirdan Imaging Limited
K192939Volumetric Specimen ImagerClarix Imaging
K183624Kubtec Mozart (Xpert42)KUB Technologies, Inc.
K183142PathVisionXLFaxitron Bioptics LLC
K182727Trident HD Specimen Radiography SystemHologic, Inc.
K173309Faxitron VisionCTFaxitron Bioptics Llc
K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics LLC
K153583BioVision PlusFAXITRON BIOPTICS LLC
K122428FAXITRON SPECIEN RADIOGRAPHY SYSTEMFAXITRON BIOPTICS LLC
K111508TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001HOLOGIC, INC.
K09192810 X 10 VISIONBIOPTICS, INC.
K091558BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEMBIOPTICS, INC.
K082432CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEMBIOPTICS, INC.

Global Unique Device Identification Database

00880304830479Cabinet,x-ray system
00880304830356Cabinet,x-ray system
00880304830301Cabinet,x-ray system
00880304830271Cabinet,x-ray system
00880304830264Cabinet,x-ray system
00880304830240Cabinet,x-ray system
00880304828339Cabinet,x-ray system
00880304828254Cabinet,x-ray system
00880304828216Cabinet,x-ray system
00880304827523Cabinet,x-ray system
00880304827486Cabinet,x-ray system
00857069006227Cabinet,X-Ray System
00857069006210Cabinet,X-Ray System
00857069006203Cabinet,X-Ray System
00857069006197Cabinet,X-Ray System

Maude Adverse Events

CABINET, X-RAY SYSTEMFAXITRON BIOPTICS, LLC2018-01-29
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