The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Ultrasound System Sonimage Mx1.
| Device ID | K180084 |
| 510k Number | K180084 |
| Device Name: | Ultrasound System SONIMAGE MX1 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Konica Minolta, Inc. 1 Sakura-machi Hino-shi, JP 191-8511 |
| Contact | Tsutomu Fukui |
| Correspondent | Russell D Munves Storch Amini PC 140 East 45th Street 25th Floor Newyork, NY 10017 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-11 |
| Decision Date | 2018-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141947016 | K180084 | 000 |