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

Cradle, Patient, Radiologic

21 CFR 892.1830 / Radiology
FDA source (opens on fda.gov)

KXH is the FDA product code for Cradle, Patient, Radiologic, a class I device type, regulated under 21 CFR 892.1830. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KXH
Device name
Cradle, Patient, Radiologic
Regulation
21 CFR 892.1830
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
9
Ingested recalls
2

Clearances, product code KXH

By decision year
9 clearances under product code KXH with a decision year between 1982 and 2012, 1993 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KXH by decision year
YearClearances
19821
19841
19861
19891
19932
19941
19951
20121

Applicants with the most clearances

Product code KXH
Applicants holding the most 510(k) clearances under product code KXH
ApplicantClearances
Octostop, Inc.3
Spectrum X-Ray Corp.3
Ar Custom Medical Products, Ltd.1
Fischer Imaging Corp.1
GE Healthcare Coils (USA Instruments, Inc.)1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order