The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Pet-512mc Transesophageal Transducer.
| Device ID | K103629 |
| 510k Number | K103629 |
| Device Name: | PET-512MC TRANSESOPHAGEAL TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-13 |
| Decision Date | 2011-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670003103 | K103629 | 000 |