The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Ultrasound System Sonimage Hs1.
| Device ID | K162065 |
| 510k Number | K162065 |
| Device Name: | Ultrasound System SONIMAGE HS1 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | KONICA MINOLTA, INC. 1 Sakura-machi Hino-shi, JP 191-8511 |
| Contact | Tsutomu Fukui |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-26 |
| Decision Date | 2016-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141946385 | K162065 | 000 |
| 04560141945470 | K162065 | 000 |
| 04560141945463 | K162065 | 000 |
| 04560141945159 | K162065 | 000 |
| 04560141945135 | K162065 | 000 |
| 04560141945111 | K162065 | 000 |
| 04560141944909 | K162065 | 000 |