The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Dynamics.
| Device ID | K123922 |
| 510k Number | K123922 |
| Device Name: | SYNGO DYNAMICS |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 400 W. MORGAN ROAD SUITE 100 Ann Arbor, MI 48108 -9117 |
| Contact | Yuri Ikeda |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-12-20 |
| Decision Date | 2013-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869227054 | K123922 | 000 |
| 04056869027142 | K123922 | 000 |
| 04056869027098 | K123922 | 000 |
| 04056869019994 | K123922 | 000 |
| 04056869259901 | K123922 | 000 |
| 04056869256399 | K123922 | 000 |
| 04056869272320 | K123922 | 000 |
| 04056869272313 | K123922 | 000 |
| 04056869247175 | K123922 | 000 |
| 04056869027159 | K123922 | 000 |
| 04056869058917 | K123922 | 000 |
| 04056869058924 | K123922 | 000 |
| 04056869227047 | K123922 | 000 |
| 04056869227030 | K123922 | 000 |
| 04056869227023 | K123922 | 000 |
| 04056869207414 | K123922 | 000 |
| 04056869207322 | K123922 | 000 |
| 04056869183190 | K123922 | 000 |
| 04056869183183 | K123922 | 000 |
| 04056869062686 | K123922 | 000 |
| 04056869247144 | K123922 | 000 |