The following data is part of a premarket notification filed by Hitachi Aloka Medical, Ltd. with the FDA for Noblus Diagnostic Ultrasound Scanner.
| Device ID | K142368 |
| 510k Number | K142368 |
| Device Name: | NOBLUS DIAGNOSTIC ULTRASOUND SCANNER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI ALOKA MEDICAL, LTD. 10 FAIRFIELD BLVD. Wallingford Ct, CT 06492 -7502 |
| Contact | Angela Van Arsdale |
| Correspondent | Angela Van Arsdale HITACHI ALOKA MEDICAL, LTD. 10 FAIRFIELD BLVD. Wallingford Ct, CT 06492 -7502 |
| 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 | 2014-08-25 |
| Decision Date | 2015-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333244157 | K142368 | 000 |
| 04562122951630 | K142368 | 000 |
| 04562122951647 | K142368 | 000 |
| 04562122951654 | K142368 | 000 |
| 04562122951661 | K142368 | 000 |
| 04562122951678 | K142368 | 000 |
| 04562122956307 | K142368 | 000 |
| 04562122956314 | K142368 | 000 |
| 04562122958066 | K142368 | 000 |
| 04562122958080 | K142368 | 000 |
| 04562122958394 | K142368 | 000 |
| 04961333244133 | K142368 | 000 |
| 04961333244140 | K142368 | 000 |
| 04562122951555 | K142368 | 000 |