Cleared Traditional

K843192 - APR MOBILE

K843192 is an FDA 510(k) clearance for APR MOBILE, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K843192 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Sep 1984
Decision
22d
Days
Class 2
Risk

K843192 is an FDA 510(k) clearance for the APR MOBILE. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Philips Medical Systems (Cleveland), Inc. devices

FDA 510(k) Submission Details - K843192

510(k) Number K843192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1984
Decision Date September 05, 1984
Days to Decision 22 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 174
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K843192.
BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100A
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