The following data is part of a premarket notification filed by Siemens Medical Systems Usa with the FDA for Syngo.mr Onco, Syngo.mr 3d Lesion Segmentation, Syngo.mr Onco Engine.
| Device ID | K111861 |
| 510k Number | K111861 |
| Device Name: | SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SYSTEMS USA 53 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Contact | Nadia Sookdeo |
| Correspondent | Nadia Sookdeo SIEMENS MEDICAL SYSTEMS USA 53 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-06-30 |
| Decision Date | 2012-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869012834 | K111861 | 000 |
| 04056869012759 | K111861 | 000 |