Cleared Traditional

K063267 - ISITE PACS, V 4. X

K063267 is an FDA 510(k) clearance for ISITE PACS, manufactured by Stentor Inc., A Philips Medical Systems Co.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K063267 · Stentor Inc., A Philips Medical Systems Co. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
10d
Days
Class 2
Risk

K063267 is an FDA 510(k) clearance for the ISITE PACS, V 4. X. 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 Stentor Inc., A Philips Medical Systems Co. (Brisbane, US). The FDA issued a Cleared decision on November 9, 2006 after a review of 10 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.

FDA 510(k) Submission Details - K063267

510(k) Number K063267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2006
Decision Date November 09, 2006
Days to Decision 10 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
97d faster than avg
Panel avg: 107d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv America, Inc.
LAURA DANIELSON

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 - LLZ System, Image Processing, Radiological

All 2284
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K063267.
IQQA-LIVER SOFTWARE
K061696 · Edda Technology, Inc. · Nov 2006
COLOR LCD MONITOR, RADIFORCE, MODEL RX210
K063120 · Eizo Nanao Corporation · Nov 2006
3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC
K063266 · Chi Lin Technology Co., Ltd. · Nov 2006
XERON PACS
K062757 · Xeron Healthcare Corp. · Nov 2006
SECTRA WORKSTATION, VERSION 11.1
K063093 · Sectra-Imtec AB · Nov 2006
GE LOGIQ WORKS
K063006 · General Electric Co. · Nov 2006
K063267 · ISITE PACS, V 4. X
Download PDF FDA Summary Stentor Inc., A Phili…