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

Scanner, Rectilinear, Nuclear

21 CFR 892.1300 / Radiology
FDA source (opens on fda.gov)

IYW is the FDA product code for Scanner, Rectilinear, Nuclear, a class I device type, regulated under 21 CFR 892.1300. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IYW
Device name
Scanner, Rectilinear, Nuclear
Regulation
21 CFR 892.1300
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
4
Ingested recalls
0

Clearances, product code IYW

By decision year
4 clearances under product code IYW with a decision year between 1978 and 1995, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IYW by decision year
YearClearances
19781
19881
19901
19951

Applicants with the most clearances

Product code IYW
Applicants holding the most 510(k) clearances under product code IYW
ApplicantClearances
Atomic Products Corp.1
Medical and Scientific Enterprises, Inc.1
Mse Medizintechnik GmbH & Co. KG1
Union Carbide Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code