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

System, Tomographic, Nuclear

21 CFR 892.1310 / Radiology
FDA source (opens on fda.gov)

JWM is the FDA product code for System, Tomographic, Nuclear, a class II device type, regulated under 21 CFR 892.1310. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JWM
Device name
System, Tomographic, Nuclear
Regulation
21 CFR 892.1310
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
17
Ingested recalls
1

Clearances, product code JWM

By decision year
17 clearances under product code JWM with a decision year between 1978 and 1991, 1985 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JWM by decision year
YearClearances
19782
19801
19812
19831
19841
19854
19871
19881
19901
19913

Applicants with the most clearances

Product code JWM
Applicants holding the most 510(k) clearances under product code JWM
ApplicantClearances
Siemens Gammasonics, Inc.4
General Electric Co.3
Toshiba Medical Systems3
Philips North America LLC2
Medtronic, Inc.2
Digital Design, Inc.1
Intl. General Electric Co.1
Toshiba America Medical Systems, In.C1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code JWM.