Submission Details
| 510(k) Number | K980687 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 23, 1998 |
| Decision Date | May 22, 1998 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
SONOS 5500 ULTRASOUND IMAGING SYSTEM
May 1998
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K980687 is an FDA 510(k) clearance for the SONOS 5500 ULTRASOUND IMAGING SYSTEM, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on May 22, 1998, 88 days after receiving the submission on February 23, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.
Device Classification
| Product Code | IYO — System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1560 |
Manufacturer
Similar Devices — IYO System, Imaging, Pulsed Echo, Ultrasonic
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