The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Harmonic Imaging And Flash Echo Imaging Function For The Diagnostic Ultrasound System Ssa-380a, Powervision 7000.
| Device ID | K981397 |
| 510k Number | K981397 |
| Device Name: | HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| 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 | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-17 |
| Decision Date | 1998-07-31 |
| Summary: | summary |