FDA Product Code MWP: Cabinet, X-ray System
Leading manufacturers include Kub Technologies, Inc., Hologic, Inc. and Faxitron Bioptics, LLC.
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
Cleared
Apr 24, 2023
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
Compai Healthcare (Suzhou) Co.,Ltd
Radiology
96d
Cleared
Apr 24, 2023
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
Compai Healthcare (Suzhou) Co.,Ltd
Radiology
96d
Cleared
Dec 22, 2021
Solas OR
Cirdan Imaging, Ltd.
Radiology
29d
Cleared
Sep 20, 2021
Kubtec Mozart Supra (XPERT 84) Radiography System
Kub Technologies, Inc.
Radiology
174d
Cleared
Aug 31, 2021
Kubtec Mozart (XPERT42)
Kub Technologies, Inc.
Radiology
154d
Cleared
Aug 31, 2021
Kubec Xpert 80 Radiography System
Kub Technologies, Inc.
Radiology
154d
Cleared
Nov 18, 2020
TrueView 100 Pro
Compai Healthcare (Shenzhen) Co.,Ltd
Radiology
63d
Cleared
Jun 12, 2020
Kubtec Mozart Supra
Kub Technologies, Inc.
Radiology
80d
Cleared
Dec 27, 2019
Volumetric Specimen Imager
Clarix Imaging
Radiology
70d
Cleared
Dec 13, 2019
CoreLite X-Ray Specimen Cabinet
Cirdan Imaging Limited
Radiology
14d
Cleared
Jun 20, 2019
Kubtec Mozart (Xpert42)
Kub Technologies, Inc.
Radiology
176d
Cleared
Mar 14, 2019
PathVisionXL
Faxitron Bioptics, LLC
Radiology
121d
Cleared
Jan 10, 2019
Trident HD Specimen Radiography System
Hologic, Inc.
Radiology
104d
Cleared
May 09, 2018
Faxitron VisionCT
Faxitron Bioptics, LLC
Radiology
203d
Cleared
Aug 19, 2011
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
Hologic, Inc.
Radiology
79d
Cleared
Jun 13, 2002
MAMMOPATH
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.