The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc with the FDA for Insight Bd.
| Device ID | K172832 |
| 510k Number | K172832 |
| Device Name: | Insight BD |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Medical Solutions, Inc 40 Liberty Boulevard 65-1A Malvern, PA 19355 |
| Contact | Denise Adams |
| Correspondent | Denise Adams Siemens Medical Solutions, Inc 40 Liberty Boulevard 65-1A Malvern, PA 19355 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-19 |
| Decision Date | 2018-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869180519 | K172832 | 000 |