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

Holder, Head, Radiographic

21 CFR 892.1920 / Radiology
FDA source (opens on fda.gov)

IWY is the FDA product code for Holder, Head, Radiographic, a class I device type, regulated under 21 CFR 892.1920. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
IWY
Device name
Holder, Head, Radiographic
Regulation
21 CFR 892.1920
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
10
Ingested recalls
1

Clearances, product code IWY

By decision year
10 clearances under product code IWY with a decision year between 1978 and 1992, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IWY by decision year
YearClearances
19781
19811
19842
19852
19871
19892
19921

Applicants with the most clearances

Product code IWY
Applicants holding the most 510(k) clearances under product code IWY
ApplicantClearances
Composites Horizons, Inc.1
Denar Corp.1
Downs Surgical, Ltd.1
Gary D. Keller1
Gary E. Hall, Dds1
Imaging Accessories, Inc.1
Knochen Dental Laboratory1
Porta-Stat, Inc.1
Rinn Corp.1
X-Ray Systems1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order