Cleared Traditional

K100372 - SAFECT MODEL VER 1.0

K100372 is an FDA 510(k) clearance for SAFECT MODEL VER 1.0, manufactured by Medic Vision Brain Technologies, Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K100372 · Medic Vision Brain Technologies, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
305d
Days
Class 2
Risk

K100372 is an FDA 510(k) clearance for the SAFECT MODEL VER 1.0. 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 Medic Vision Brain Technologies, Ltd. (Haifa, IL). The FDA issued a Cleared decision on December 14, 2010 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate-to-high equivalence dependency. 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 Medic Vision Brain Technologies, Ltd. devices

FDA 510(k) Submission Details - K100372

510(k) Number K100372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date December 14, 2010
Days to Decision 305 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 107d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1309
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K100372.
NEUCOLONCARE
K110077 · Neusoft Medical Systems Co., Ltd. · Jan 2011
Q-STATION
K103815 · Philips Ultrasound, Inc. · Jan 2011
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K103182 · Genoray Co., Ltd. · Jan 2011
20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)
K092728 · Totoku Electric Co., Ltd. · Nov 2010
BEYONDIMAGE WORKSTATION
K102435 · Neusoft Medical Systems Co., Ltd. · Oct 2010
4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
K101166 · Ge Healthcare · Oct 2010