K122174 is an FDA 510(k) clearance for the PEDIATRIC POSITIONER PAD SET. This device is classified as a Cradle, Patient, Radiologic (Class I - General Controls, product code KXH).
Submitted by Ge Healthcare Coils (Usa Instruments, Inc.) (Aurora, US). The FDA issued a Cleared decision on November 16, 2012, 116 days after receiving the submission on July 23, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1830.
| 510(k) Number | K122174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2012 |
| Decision Date | November 16, 2012 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KXH — Cradle, Patient, Radiologic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1830 |