The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System.
Device ID | K110870 |
510k Number | K110870 |
Device Name: | APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM |
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 |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-29 |
Decision Date | 2011-10-04 |
Summary: | summary |