510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
IYZClass I

Bed, Scanning, Nuclear

21 CFR 892.1350 / Radiology
FDA source (opens on fda.gov)

IYZ is the FDA product code for Bed, Scanning, Nuclear, a class I device type, regulated under 21 CFR 892.1350. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IYZ
Device name
Bed, Scanning, Nuclear
Regulation
21 CFR 892.1350
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code IYZ

By decision year
12 clearances under product code IYZ with a decision year between 1989 and 1992, 1991 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code IYZ by decision year
YearClearances
19891
19902
19917
19922

Applicants with the most clearances

Product code IYZ
Applicants holding the most 510(k) clearances under product code IYZ
ApplicantClearances
Med-Tron Products, Inc.6
Siemens Gammasonics, Inc.3
Atomic Products Corp.1
Nu Age Products1
Qrsystems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code