The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Ultrasound System Sonimage Hs 1.
| Device ID | K152577 |
| 510k Number | K152577 |
| Device Name: | ULTRASOUND SYSTEM SONIMAGE HS 1 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | KONICA MINOLTA, INC. 1 SAKURA-MACHI Hino-shi, JP 191-8511 |
| Contact | Shigeyuki Kojima |
| Correspondent | Russell D. Munves STORCH AMINI & MUNVES PC 140 EAST 45TH STREET, 25TH FLOOR New York, NY 10017 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-09 |
| Decision Date | 2015-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141944534 | K152577 | 000 |
| 04560141944350 | K152577 | 000 |