The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo, Ct Bone Reading.
| Device ID | K123584 |
| 510k Number | K123584 |
| Device Name: | SYNGO, CT BONE READING |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Kimberly Mangum |
| Correspondent | Kimberly Mangum SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869026428 | K123584 | 000 |
| 04056869013954 | K123584 | 000 |
| 04056869007861 | K123584 | 000 |