Cleared Traditional

K090808 - PINNACLE3 SMARTARC

K090808 is an FDA 510(k) clearance for PINNACLE3 SMARTARC, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K090808 · Philips Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
9d
Days
Class 2
Risk

K090808 is an FDA 510(k) clearance for the PINNACLE3 SMARTARC. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Fitchburg, US). The FDA issued a Cleared decision on April 3, 2009 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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.

FDA 510(k) Submission Details - K090808

510(k) Number K090808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2009
Decision Date April 03, 2009
Days to Decision 9 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 107d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 257
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K090808.
MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)
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K091146 · Accuray, Inc. · May 2009
P.D SOFTWARE
K083672 · .Decimal, Inc. · Apr 2009
RADIONICS XKNIFE HDRT SYSTEM
K083414 · Integra Radionics, Inc. · Mar 2009
RAYAUTOPLAN 1.0
K083264 · Raysearch Laboratories AB · Jan 2009
COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS)
K082606 · D3 Radiation Planning · Nov 2008
K090808 · PINNACLE3 SMARTARC
Download PDF FDA Summary Philips Medical Syste…