Cleared Special

K093355 - PCR ELEVA 1.2

K093355 is the FDA 510(k) clearance for PCR ELEVA 1.2 by Philips Medical Systems, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Special 510(k) pathway after a 73-day FDA review.

K093355 · Philips Medical Systems, Inc. · Radiology device
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Jan 2010
Decision
73d
Days
Class 2
Risk

K093355 is an FDA 510(k) clearance for the PCR ELEVA 1.2. 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. (Bothell, US). The FDA issued a Cleared decision on January 8, 2010 after a review of 73 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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

Submission Details

510(k) Number K093355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2009
Decision Date January 08, 2010
Days to Decision 73 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 107d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 1127
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