The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Nemio Xg, Saa-580a.
| Device ID | K061605 |
| 510k Number | K061605 |
| Device Name: | NEMIO XG, SAA-580A |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2006-06-09 |
| Decision Date | 2006-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670002809 | K061605 | 000 |
| 04987670001154 | K061605 | 000 |
| 04987670001147 | K061605 | 000 |
| 04987670001123 | K061605 | 000 |
| 04987670001109 | K061605 | 000 |
| 04987670000812 | K061605 | 000 |
| 04987670000805 | K061605 | 000 |
| 04987670000799 | K061605 | 000 |
| 04987670000782 | K061605 | 000 |
| 04987670000775 | K061605 | 000 |
| 04987670000645 | K061605 | 000 |
| 04987670000522 | K061605 | 000 |
| 04987670000492 | K061605 | 000 |
| 04987670001161 | K061605 | 000 |
| 04987670001383 | K061605 | 000 |
| 04987670001413 | K061605 | 000 |
| 04987670002793 | K061605 | 000 |
| 04987670002786 | K061605 | 000 |
| 04987670001680 | K061605 | 000 |
| 04987670001673 | K061605 | 000 |
| 04987670001666 | K061605 | 000 |
| 04987670001642 | K061605 | 000 |
| 04987670001628 | K061605 | 000 |
| 04987670001611 | K061605 | 000 |
| 04987670001604 | K061605 | 000 |
| 04987670001468 | K061605 | 000 |
| 04987670001451 | K061605 | 000 |
| 04987670001444 | K061605 | 000 |
| 04987670000478 | K061605 | 000 |