Cleared Traditional

K964288 - CALL-RAD PC TELERADIOLOGY

K964288 is an FDA 510(k) clearance for CALL-RAD PC TELERADIOLOGY, manufactured by Pc Teleradiology. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K964288 · Pc Teleradiology · Radiology device
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Apr 1997
Decision
177d
Days
Class 2
Risk

K964288 is an FDA 510(k) clearance for the CALL-RAD PC TELERADIOLOGY. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Pc Teleradiology (Salt Lake City, US). The FDA issued a Cleared decision on April 23, 1997 after a review of 177 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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 Pc Teleradiology devices

FDA 510(k) Submission Details - K964288

510(k) Number K964288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1996
Decision Date April 23, 1997
Days to Decision 177 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 107d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMA Device Classification - Class 2, Special Controls

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 - LMA Digitizer, Image, Radiological

All 25
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K964288.
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
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HOWTEK 960
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FILM SCANNER 300
K960839 · Cannon U.S.A., Inc. · Dec 1996
KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
K961768 · Kodak Health Imaging Systems, Inc. · Aug 1996
SCANMASTER DX
K953117 · Howtek, Inc. · Jan 1996