Cleared Traditional

K875251 - ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE

K875251 is the FDA 510(k) clearance for ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K875251 · Philips Medical Systems (Cleveland), Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
141d
Days
Class 2
Risk

K875251 is an FDA 510(k) clearance for the ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on May 11, 1988 after a review of 141 days - within the typical 510(k) review window.

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. 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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K875251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date May 11, 1988
Days to Decision 141 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
34d slower than avg
Panel avg: 107d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 388
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K875251.
NIDEK US-3000
K882162 · Nidek, Inc. · Aug 1988
ENDOVAGINAL PROBE, SMS-510VA
K882959 · Toshiba Medical Systems · Aug 1988
MODIFIED MODEL SSD-650 SYSTEM
K873452 · Ge Medical Systems Information Technologies · Jul 1988
7.5 MHZ ENDORECTAL PROBE
K881028 · Philips Ultrasound, Inc. · Apr 1988
DIASONICS QT ENDORECTAL 7.5 MHZ PROBE
K880714 · Diasonics, Inc. · Apr 1988
THE ESI-2000 ULTRASOUND UNIT
K874683 · Elscint, Inc. · Apr 1988