Atlas FDA

MWP

27 FDA 510(k) clearances · Product code

91 daysmedian time to decision
176 days90th percentile
27clearances measured

FDA profile

Official device name
Cabinet, X-Ray System
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1680
Medical specialty
Radiology
Flags
Third-party review eligible
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RecordFirmDate
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) (K230140)Compai Healthcare (Suzhou) Co.,Ltd2023-04-24
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) (K230136)Compai Healthcare (Suzhou) Co.,Ltd2023-04-24
Solas OR (K213691)Cirdan Imaging, Ltd.2021-12-22
Kubtec Mozart Supra (XPERT 84) Radiography System (K210955)Kub Technologies, Inc.2021-09-20
Kubtec Mozart (XPERT42) (K210956)Kub Technologies, Inc.2021-08-31
Kubec Xpert 80 Radiography System (K210957)Kub Technologies, Inc.2021-08-31
TrueView 100 Pro (K202713)Compai Healthcare (Shenzhen) Co.,Ltd2020-11-18
Kubtec Mozart Supra (K200756)Kub Technologies, Inc.2020-06-12
Volumetric Specimen Imager (K192939)Clarix Imaging2019-12-27
CoreLite X-Ray Specimen Cabinet (K193317)Cirdan Imaging Limited2019-12-13
Kubtec Mozart (Xpert42) (K183624)Kub Technologies, Inc.2019-06-20
PathVisionXL (K183142)Faxitron Bioptics, LLC2019-03-14
Trident HD Specimen Radiography System (K182727)Hologic, Inc.2019-01-10
Faxitron VisionCT (K173309)Faxitron Bioptics, LLC2018-05-09
Faxitron Bioptics Speciemen Radiography System (K170786)Faxitron Bioptics, LLC2017-07-18
BioVision Plus (K153583)Faxitron Bioptics, LLC2016-04-01
FAXITRON SPECIEN RADIOGRAPHY SYSTEM (K122428)Faxitron Bioptics, LLC2012-09-25
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 (K111508)Hologic, Inc.2011-08-19
10 X 10 VISION (K091928)Bioptics, Inc.2010-06-16
BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM (K091558)Bioptics, Inc.2009-07-17
CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM (K082432)Bioptics, Inc.2008-11-21
FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 (K072557)Faxitron X-Ray Corp.2007-10-30
XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM (K071233)Kub Technologies, Inc.2007-06-20
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 (K061361)Faxitron X-Ray Corp.2006-08-15
PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM (K052433)Bioptics, Inc.2005-10-18
MAMMOPATH (K021113)Fischer Imaging Corp.2002-06-13
MICRO-FOCUS 50 CABINET X-RAY (K852634)Micro-Focus Imaging., Inc.1985-07-19

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Every clearance here is in the API, with alerts when new ones post.