The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Sc2000 And Acuson X300 Diagnostic Ultrasound Systems.
| Device ID | K142395 |
| 510k Number | K142395 |
| Device Name: | SC2000 And ACUSON X300 Diagnostic Ultrasound Systems |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Shelly Pearce |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | OBJ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-08-27 |
| Decision Date | 2014-09-09 |
| Summary: | summary |