MWP · Class II · 21 CFR 892.1680

FDA Product Code MWP: Cabinet, X-ray System

Leading manufacturers include Kub Technologies, Inc., Faxitron Bioptics, LLC and Faxitron X-Ray Corp..

27
Total
27
Cleared
100d
Avg days
1985
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Cabinet, X-ray System Devices (Product Code MWP)

27 devices
1–24 of 27
Cleared Apr 24, 2023
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
K230136
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d
Cleared Apr 24, 2023
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
K230140
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d
Cleared Dec 22, 2021
Solas OR
K213691
Cirdan Imaging, Ltd.
Radiology · 29d
Cleared Sep 20, 2021
Kubtec Mozart Supra (XPERT 84) Radiography System
K210955
Kub Technologies, Inc.
Radiology · 174d
Cleared Aug 31, 2021
Kubtec Mozart (XPERT42)
K210956
Kub Technologies, Inc.
Radiology · 154d
Cleared Aug 31, 2021
Kubec Xpert 80 Radiography System
K210957
Kub Technologies, Inc.
Radiology · 154d
Cleared Nov 18, 2020
TrueView 100 Pro
K202713
Compai Healthcare (Shenzhen) Co.,Ltd
Radiology · 63d
Cleared Jun 12, 2020
Kubtec Mozart Supra
K200756
Kub Technologies, Inc.
Radiology · 80d
Cleared Dec 27, 2019
Volumetric Specimen Imager
K192939
Clarix Imaging
Radiology · 70d
Cleared Dec 13, 2019
CoreLite X-Ray Specimen Cabinet
K193317
Cirdan Imaging Limited
Radiology · 14d
Cleared Jun 20, 2019
Kubtec Mozart (Xpert42)
K183624
Kub Technologies, Inc.
Radiology · 176d
Cleared Mar 14, 2019
PathVisionXL
K183142
Faxitron Bioptics, LLC
Radiology · 121d
Cleared Jan 10, 2019
Trident HD Specimen Radiography System
K182727
Hologic, Inc.
Radiology · 104d
Cleared May 09, 2018
Faxitron VisionCT
K173309
Faxitron Bioptics, LLC
Radiology · 203d
Cleared Jul 18, 2017
Faxitron Bioptics Speciemen Radiography System
K170786
Faxitron Bioptics, LLC
Radiology · 124d
Cleared Apr 01, 2016
BioVision Plus
K153583
Faxitron Bioptics, LLC
Radiology · 108d
Cleared Sep 25, 2012
FAXITRON SPECIEN RADIOGRAPHY SYSTEM
K122428
Faxitron Bioptics, LLC
Radiology · 47d
Cleared Aug 19, 2011
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
K111508
Hologic, Inc.
Radiology · 79d
Cleared Oct 30, 2007
FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20
K072557
Faxitron X-Ray Corp.
Radiology · 49d
Cleared Jun 20, 2007
XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM
K071233
Kub Technologies, Inc.
Radiology · 48d
Cleared Aug 15, 2006
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
K061361
Faxitron X-Ray Corp.
Radiology · 91d
Cleared Oct 18, 2005
PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
K052433
Bioptics, Inc.
Radiology · 42d
Cleared Jun 13, 2002
MAMMOPATH
K021113
Fischer Imaging Corp.
Radiology · 69d

About Product Code MWP - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code MWP since 1985, with 27 receiving FDA clearance (average review time: 100 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.