The following data is part of a premarket notification filed by Hitachi Aloka Medical, Ltd. with the FDA for Prosound F37 Diagnostic Ultrasound System, Model: Prosound F37.
| Device ID | K122341 |
| 510k Number | K122341 |
| Device Name: | PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI ALOKA MEDICAL, LTD. 10 FAIRFIELD BLVD. Wallingford Ct, CT 06492 -7502 |
| Correspondent | Michael S Ogunleye TUV RHEINLAND OF NORTH AMERICA, INC. 1279 QUARRY LANE, SUITE A Pleasanton, CA 94566 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2012-08-02 |
| Decision Date | 2012-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122957878 | K122341 | 000 |
| 04562122956291 | K122341 | 000 |
| 04573596214145 | K122341 | 000 |
| 04573596210345 | K122341 | 000 |