Cleared Abbreviated

K012563 - DEEP GRAY

K012563 is an FDA 510(k) clearance for DEEP GRAY, manufactured by Cortechs Labs, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Abbreviated 510(k) pathway after a 85-day FDA review.

K012563 · Cortechs Labs, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
85d
Days
Class 2
Risk

K012563 is an FDA 510(k) clearance for the DEEP GRAY. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Cortechs Labs, Inc. (Charlestown, US). The FDA issued a Cleared decision on November 2, 2001 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Incremental AI imaging tool. Standards-verified equivalence. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Cortechs Labs, Inc. devices

FDA 510(k) Submission Details - K012563

510(k) Number K012563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2001
Decision Date November 02, 2001
Days to Decision 85 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Standards-based clearance path.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1193
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K012563.
IMAGEDESK
K020061 · Barco N.V. · Apr 2002
ADVANTAGE WORKSTATION 4.1
K020483 · GE Medical Systems · Feb 2002
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM
K013922 · Barco N.V. · Jan 2002
CAAS II QVA
K012475 · Pie Medical Imaging BV · Oct 2001
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
K012155 · Eastman Kodak Company · Aug 2001
MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES
K012099 · Totoku Electric Co., Ltd. · Jul 2001