The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Ultraextend Usws-900a V2.1 And V3.1.
| Device ID | K131822 |
| 510k Number | K131822 |
| Device Name: | ULTRAEXTEND USWS-900A V2.1 AND V3.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 -2068 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-06-20 |
| Decision Date | 2013-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670101014 | K131822 | 000 |