Deep Gray
510(k) K012563
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012563 | Date2 Nov 2001 | StatusActive |
Official records
- FDA 510(k) database K012563
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Cortechs Labs, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
Deep Gray is a medical imaging system. It is designed to function as a tool for the processing and analysis of medical images.
This device is supplied by Cortechs Labs Inc and has received FDA 510k clearance. It is categorized under the radiology advisory committee.
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- DirectPath by Cybernet Systems Co., Ltd.
- FyreLink by Mpacs, LLC
- EV Insite System by Psp Corporation
- Netra Workstation and NetraMD Software by Scimage, Inc.
- Fcr Fuji Computed Radiography Dms Crt Image Console HI-C654 by Fujifilm Medical System U.S.A., Inc.
- GenIQ by GE MEDICAL SYSTEMS, INC.
- 3-D Imaging Workstation by Eigen
- Vitrea Software Package VSTP-002A by CANON INC.
- EUNITY by Client Outlook, Inc.
- Barco Medical Display Conformity and Consistency Software by Barco N.V.