Cleared Traditional

K853565 - ARTIS ULTRASOUND IMAGING SYSTEM

K853565 is an FDA 510(k) clearance for ARTIS ULTRASOUND IMAGING SYSTEM, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K853565 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Jun 1986
Decision
308d
Days
Class 2
Risk

K853565 is an FDA 510(k) clearance for the ARTIS ULTRASOUND IMAGING SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Northford, US). The FDA issued a Cleared decision on June 30, 1986 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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. Elevated predicate reliance profile. 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 Philips Medical Systems (Cleveland), Inc. devices

FDA 510(k) Submission Details - K853565

510(k) Number K853565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date June 30, 1986
Days to Decision 308 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
201d slower than avg
Panel avg: 107d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 640
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K853565.
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