The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Xario 200, V3.0.
| Device ID | K143027 |
| 510k Number | K143027 |
| Device Name: | Xario 200, V3.0 |
| 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 | 2014-10-21 |
| Decision Date | 2014-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670100765 | K143027 | 000 |
| 04987670003394 | K143027 | 000 |
| 04987670003387 | K143027 | 000 |
| 04987670003370 | K143027 | 000 |
| 04987670003363 | K143027 | 000 |
| 04987670003356 | K143027 | 000 |
| 04987670003349 | K143027 | 000 |
| 04987670003332 | K143027 | 000 |
| 04987670003325 | K143027 | 000 |
| 04987670003318 | K143027 | 000 |
| 04987670003400 | K143027 | 000 |
| 04987670003417 | K143027 | 000 |
| 04987670100758 | K143027 | 000 |
| 04987670004391 | K143027 | 000 |
| 04987670004377 | K143027 | 000 |
| 04987670004230 | K143027 | 000 |
| 04987670004223 | K143027 | 000 |
| 04987670004216 | K143027 | 000 |
| 04987670004209 | K143027 | 000 |
| 04987670003431 | K143027 | 000 |
| 04987670003424 | K143027 | 000 |
| 04987670003301 | K143027 | 000 |