Cleared Traditional

K974863 - IMIX DIGITAL THORAX SYSTEM

K974863 is an FDA 510(k) clearance for IMIX DIGITAL THORAX SYSTEM, manufactured by Advanced Instrument Development, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K974863 · Advanced Instrument Development, Inc. · Radiology device
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Mar 1998
Decision
78d
Days
Class 2
Risk

K974863 is an FDA 510(k) clearance for the IMIX DIGITAL THORAX SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Advanced Instrument Development, Inc. (Melrose Park, US). The FDA issued a Cleared decision on March 17, 1998 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Advanced Instrument Development, Inc. devices

FDA 510(k) Submission Details - K974863

510(k) Number K974863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1997
Decision Date March 17, 1998
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 262
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K974863.
PHILIPS THORAVISION
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K981056 · Varian Medical Systems, Inc. · Jun 1998
OLDELFT DIGIDELCA
K980296 · Oldelft Corp. of America · Apr 1998
ADC COMPACT (AGFA DIAGNOSTIC CENTER)
K974597 · Bayer Corp., Agfa Div. · Mar 1998
VACUDAP, MODEL 2000, 2001
K974112 · Victoreen, Inc. · Jan 1998
DIGITAL ADD ON MULTI SYSTEM
K973710 · Swissray International, Inc. · Dec 1997