The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc with the FDA for Acuson Sc2000 Diagnostic Ultrasound System.
Device ID | K181098 |
510k Number | K181098 |
Device Name: | ACUSON SC2000 Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | Siemens Medical Solutions USA, Inc 685 East Middlefield Road Mountain View, CA 94043 |
Contact | Christine Dunbar |
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 |
Subsequent Product Code | OBJ |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2018-04-26 |
Decision Date | 2018-05-31 |
Summary: | summary |