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510(k) K122174

PEDIATRIC POSITIONER PAD SET by Ge Healthcare Coils (Usa Instruments, Inc.) — Product Code KXH

K122174 is an FDA 510(k) premarket notification submitted by Ge Healthcare Coils (Usa Instruments, Inc.) for the device "PEDIATRIC POSITIONER PAD SET". The FDA issued a decision of Substantially Equivalent on November 16, 2012. The device falls under product code KXH (Cradle, Patient, Radiologic), a Class I device regulated under 21 CFR 892.1830. Ge Healthcare Coils (Usa Instruments, Inc.) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2012
Date Received
July 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cradle, Patient, Radiologic
Device Class
Class I
Regulation Number
892.1830
Review Panel
RA
Submission Type

Other clearances by Ge Healthcare Coils (Usa Instruments, Inc.)

  • K253738 — 3.0T AIR 32CH HNA (January 23, 2026)
  • K223378 — 3.0T 16ch AIR AA (January 3, 2023)
  • K182504 — 3.0T Air MP M, 3.0T Air MP L (October 12, 2018)
  • K180666 — 48CH Head Coil (April 12, 2018)
  • K172695 — AIR Anterior Array, AIR Posterior Array (November 22, 2017)
  • K163205 — 48CH Head Coil (January 12, 2017)
  • K143389 — 3.0T GEM RT Open Array (March 6, 2015)
  • K123327 — 1.5T GEM RT OPEN ARRAY (January 11, 2013)
  • K103365 — DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COI (January 12, 2011)
  • K101492 — 8 CHANNEL CARDIAC PHASED ARRAY COIL (June 23, 2010)

Other clearances for product code KXH

  • K953246 — OCTOROLL (September 29, 1995)
  • K930124 — VARIANT OF OCTOSTOP AND OCTOPAQUE (February 9, 1994)
  • K933134 — SPECTRUM DG-P7000 PEDIATRIC CRADLE (October 7, 1993)
  • K930357 — ACCESSORY TO UNIVERSAL OCTOPAQUE (July 13, 1993)
  • K884292 — STRETCHER TABLE (March 31, 1989)
  • K863890 — MAMM-AIRE (October 14, 1986)
  • K840463 — DIGITAL CRADLE (February 21, 1984)
  • K813561 — SPECTRUM PEDIATRIC CARDLE TABLE (January 29, 1982)

FDA data resources