The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Phased Array Transducer - - Psk-20ct.
| Device ID | K970047 |
| 510k Number | K970047 |
| Device Name: | PHASED ARRAY TRANSDUCER - - PSK-20CT |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Steven M Kay |
| Correspondent | Steven M Kay TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-06 |
| Decision Date | 1997-03-04 |
| Summary: | summary |