510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122174Substantially Equivalent

Pediatric Positioner Pad Set

GE Healthcare Coils (USA Instruments, Inc.), Aurora OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122174 is the FDA 510(k) clearance record for PEDIATRIC POSITIONER PAD SET, a class I device, cleared for Ge Healthcare Coils (Usa Instruments, Inc.) on under FDA product code KXH (Cradle, Patient, Radiologic). FDA records list 12 510(k) clearances for Ge Healthcare Coils (Usa Instruments, Inc.), from to . As of , FDA records show no recalls naming K122174.

Clearance record

Decision date
Received
(116 days to decision)
Product code
KXH Cradle, Patient, Radiologic
Regulation
21 CFR 892.1830
Device class
Class I
Review panel
Radiology
Applicant
Ge Healthcare Coils (Usa Instruments, Inc.) 1515 Danner Dr., Aurora OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KXH

Trailing 12 months

FDA records hold no clearances under product code KXH in the trailing twelve months.

FDA records show no clearances under product code KXH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260