The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Xario 100 Diagnostic Ultrasound System, V5.0.
| Device ID | K162187 |
| 510k Number | K162187 |
| Device Name: | Xario 100 Diagnostic Ultrasound System, V5.0 |
| 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 | 2016-08-04 |
| Decision Date | 2016-09-30 |
| Summary: | summary |