Submission Details
| 510(k) Number | K971116 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 26, 1997 |
| Decision Date | January 12, 1998 |
| Days to Decision | 292 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
SONOS 5500 IMAGING SYSTEM
Jan 1998
Decision
292d
Days
Class 2
Risk
About This 510(k) Submission
K971116 is an FDA 510(k) clearance for the SONOS 5500 IMAGING SYSTEM, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on January 12, 1998, 292 days after receiving the submission on March 26, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.
Device Classification
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1570 |
Manufacturer
Similar Devices — ITX Transducer, Ultrasonic, Diagnostic
All 408
K250883 · Olympus Medical Systems Corporation
· Sep 2025
K250762 · Olympus Medical Systems Corporation
· Jul 2025
K250524 · Mendaera, Inc.
· Jul 2025
K250469 · Rivanna Medical, Inc.
· Jun 2025
K241662 · Vitrolife Sweden AB
· Aug 2024
K233965 · Parker Laboratories, Inc.
· Aug 2024
More from Hewlett-Packard Co.
View all
K992543
· MKJ · May 2000
K993587
· MQS · Jan 2000
K993169
· DRG · Dec 1999
K992977
· MKJ · Dec 1999
K993516
· DSI · Nov 1999