The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Ultraextend Fx, Ultrasound Workstation Package.
| Device ID | K121076 |
| 510k Number | K121076 |
| Device Name: | ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE |
| Classification | System, Image Processing, Radiological |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92781 -2068 |
| Contact | Charlemagne Chua |
| Correspondent | Charlemagne Chua TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92781 -2068 |
| Product Code | LLZ |
| Subsequent Product Code | IYL |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-09 |
| Decision Date | 2012-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670100796 | K121076 | 000 |