The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Aplio I900/i800/i700 Diagnostic Ultrasound System, V2.0.
| Device ID | K161843 |
| 510k Number | K161843 |
| Device Name: | Aplio I900/i800/i700 Diagnostic Ultrasound System, V2.0 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 SHIMOISHIGAMI Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Orlando Tadeo TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DRIVE Tustin, CA 92780 |
| 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 | 2016-07-05 |
| Decision Date | 2016-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670102523 | K161843 | 000 |
| 04987670102516 | K161843 | 000 |
| 04987670102509 | K161843 | 000 |
| 04987670004506 | K161843 | 000 |
| 04987670004490 | K161843 | 000 |
| 04987670004483 | K161843 | 000 |
| 04987670004476 | K161843 | 000 |
| 04987670004469 | K161843 | 000 |
| 04987670004452 | K161843 | 000 |