The following data is part of a premarket notification filed by Cortechs Labs, Inc. with the FDA for Deep Gray.
| Device ID | K012563 |
| 510k Number | K012563 |
| Device Name: | DEEP GRAY |
| Classification | System, Image Processing, Radiological |
| Applicant | CORTECHS LABS, INC. 6 13TH ST. Charlestown, MA 02129 -2027 |
| Contact | Jeffrey M Anders |
| Correspondent | Jeffrey M Anders CORTECHS LABS, INC. 6 13TH ST. Charlestown, MA 02129 -2027 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-09 |
| Decision Date | 2001-11-02 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DEEP GRAY 98207589 not registered Live/Pending |
Deep Gray LLC 2023-10-03 |
![]() DEEP GRAY 78075298 2854898 Dead/Cancelled |
Halgren, Eric 2001-07-23 |