The following data is part of a premarket notification filed by Konica Minolta Inc. with the FDA for Ultrasound System Sonimage Hs1, Linear Probe L18-4, Convex Probe C5-2.
| Device ID | K142197 |
| 510k Number | K142197 |
| Device Name: | ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | KONICA MINOLTA INC. 1 SAKUA-MACHI Hino-shi, JP 191-8511 |
| Contact | Shigeyuki Kojima |
| Correspondent | Russel 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 | 2014-08-11 |
| Decision Date | 2014-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141940178 | K142197 | 000 |
| 04560141940161 | K142197 | 000 |
| 04560141940031 | K142197 | 000 |