Cleared Traditional

K955237 - TIGERSCAN/TIGERVIEW

K955237 is an FDA 510(k) clearance for TIGERSCAN/TIGERVIEW, manufactured by Tau Corp.. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K955237 · Tau Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
142d
Days
Class 1
Risk

K955237 is an FDA 510(k) clearance for the TIGERSCAN/TIGERVIEW. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Tau Corp. (Los Gatos, US). The FDA issued a Cleared decision on April 4, 1996 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2010 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tau Corp. devices

FDA 510(k) Submission Details - K955237

510(k) Number K955237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1995
Decision Date April 04, 1996
Days to Decision 142 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 107d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

LMB Device Classification - Class 1, General Controls

Product Code LMB Device, Digital Image Storage, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2010
Definition Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LMB Device, Digital Image Storage, Radiological

All 33
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K955237.
KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY
K960981 · Kodak Health Imaging Systems, Inc. · Jun 1996
UPACS
K960941 · Base Ten Systems, Inc. · Jun 1996
LAST IMAGE HOLD
K951942 · Insight Systems · Apr 1996
FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM
K960326 · Fujifilm Medical System U.S.A., Inc. · Mar 1996
VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE)
K952238 · Imaging Concepts, Inc. · Feb 1996
ACCULUPE
K955184 · E For M Imaging Systems Div., Marquette Electronic · Jan 1996