510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MWPClass II

Cabinet, X-Ray System

21 CFR 892.1680 / Radiology
FDA source (opens on fda.gov)

MWP is the FDA product code for Cabinet, X-Ray System, a class II device type, regulated under 21 CFR 892.1680. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MWP
Device name
Cabinet, X-Ray System
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
27
Ingested recalls
0

Clearances, product code MWP

By decision year
27 clearances under product code MWP with a decision year between 1985 and 2023, 2019 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code MWP by decision year
YearClearances
19851
20021
20051
20061
20072
20081
20091
20101
20111
20121
20161
20171
20181
20195
20202
20214
20232

Applicants with the most clearances

Product code MWP
Applicants holding the most 510(k) clearances under product code MWP
ApplicantClearances
Kub Technologies, Inc.6
Faxitron Bioptics, LLC5
Bioptics, Inc.4
Cirdan Imaging Limited2
Compai Healthcare (Suzhou) Co.,Ltd2
Faxitron X-Ray Corp.2
Hologic, Inc.2
Clarix Imaging Corp1
Compai Healthcare (Shenzhen) Co.,Ltd1
Fischer Imaging Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code