The following data is part of a premarket notification filed by Siemens Medical Solutions with the FDA for Syngo Trued Software.
| Device ID | K101749 |
| 510k Number | K101749 |
| Device Name: | SYNGO TRUED SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS 20 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Contact | James E Kuhn |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-22 |
| Decision Date | 2010-08-16 |
| Summary: | summary |