K022303 is an FDA 510(k) clearance for the PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Philips Ultrasound, Inc. (Andover, US). The FDA issued a Cleared decision on July 30, 2002, 14 days after receiving the submission on July 16, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K022303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2002 |
| Decision Date | July 30, 2002 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN - System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |