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

Collimator, Automatic, Radiographic

21 CFR 892.1610 / Radiology
FDA source (opens on fda.gov)

IZW is the FDA product code for Collimator, Automatic, Radiographic, a class II device type, regulated under 21 CFR 892.1610. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
IZW
Device name
Collimator, Automatic, Radiographic
Regulation
21 CFR 892.1610
Device class
Class II
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
23
Ingested recalls
3

Clearances, product code IZW

By decision year
23 clearances under product code IZW with a decision year between 1981 and 2010, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IZW by decision year
YearClearances
19812
19842
19862
19891
19911
19922
19951
19961
19981
19991
20031
20051
20072
20081
20092
20102

Applicants with the most clearances

Product code IZW
Applicants holding the most 510(k) clearances under product code IZW
ApplicantClearances
Philips North America LLC3
Omega Medical Imaging, LLC2
Ralco S.r.l.2
Shimadzu Corp.2
Shimadzu Medical Systems2
Collimare, LLC1
D&R X-Ray Products, Inc.1
Dealers X-Ray Co., Inc.1
GE Healthcare1
Midmark Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order