The following data is part of a premarket notification filed by Segami Corporation with the FDA for Dgscope, Release 1.0.
| Device ID | K070397 |
| 510k Number | K070397 |
| Device Name: | DGSCOPE, RELEASE 1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | SEGAMI CORPORATION 8325-B GUILFORD ROAD Columbia, MD 21046 |
| Contact | Philippe Briandet |
| Correspondent | Philippe Briandet SEGAMI CORPORATION 8325-B GUILFORD ROAD Columbia, MD 21046 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-12 |
| Decision Date | 2007-04-13 |