The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acuson Juniper Diagnostic Ultrasound System And Acuson Juniper Select Diagnostic Ultrasound System.
| Device ID | K221190 |
| 510k Number | K221190 |
| Device Name: | ACUSON Juniper Diagnostic Ultrasound System And ACUSON Juniper Select Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Siemens Medical Solutions USA, Inc. 22010 South East 51st Street Issaquah, WA 98029 |
| Contact | Sulgue Choi |
| Correspondent | Sulgue Choi Siemens Medical Solutions USA, Inc. 22010 South East 51st Street Issaquah, WA 98029 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | OIJ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869957357 | K221190 | 000 |
| 04056869285887 | K221190 | 000 |
| 04056869283401 | K221190 | 000 |