Cleared Traditional

K951141 - STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER

K951141 is an FDA 510(k) clearance for STAR TECHNOLGIES, manufactured by Star Technologies, Inc.. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K951141 · Star Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
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May 1995
Decision
78d
Days
Class 1
Risk

K951141 is an FDA 510(k) clearance for the STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Star Technologies, Inc. (Sterling, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 78 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Star Technologies, Inc. devices

FDA 510(k) Submission Details - K951141

510(k) Number K951141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1995
Decision Date May 30, 1995
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
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 34
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K951141.
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