Cleared Traditional

K915237 - PHILIPS PCR-ACE SYSTEM

K915237 is an FDA 510(k) clearance for PHILIPS PCR-ACE SYSTEM, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K915237 · Philips Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
48d
Days
Class 2
Risk

K915237 is an FDA 510(k) clearance for the PHILIPS PCR-ACE SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on January 9, 1992 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Philips Medical Systems, Inc. devices

FDA 510(k) Submission Details - K915237

510(k) Number K915237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date January 09, 1992
Days to Decision 48 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
59d faster than avg
Panel avg: 107d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1926
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K915237.
SIENET DIAGNOSTIC REPORTING CONSOLE
K920309 · Siemens Gammasonics, Inc. · Mar 1992
MEDRAD PATHFINDER HR ROADMAPPING SYSTEM
K914366 · Medrad, Inc. · Feb 1992
OPTION U1 FOR THE DPS-PLUS SYSTEM
K915305 · Adac Laboratories · Feb 1992
HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE
K913264 · Mallinckrodt Group, Inc. · Nov 1991
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR 7501
K910437 · Fujifilm Medical System U.S.A., Inc. · Apr 1991
SHIMADZU IMAGE PROCESSOR DFS-500
K905132 · Shimadzu Medical Systems · Apr 1991