The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Aplio I900/i800/i700/i600 Diagnostic Ultrasound System, V2.4.
| Device ID | K173090 |
| 510k Number | K173090 |
| Device Name: | Aplio I900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 |
| 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 | 2017-09-29 |
| Decision Date | 2018-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670102981 | K173090 | 000 |