Cleared Traditional

K936272 - PHILIPS TOMOSCAN SR 4000

K936272 is the FDA 510(k) clearance for PHILIPS TOMOSCAN SR 4000 by Philips Medical Systems North America, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K936272 · Philips Medical Systems North America, Inc. · Radiology device
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Oct 1994
Decision
285d
Days
Class 2
Risk

K936272 is an FDA 510(k) clearance for the PHILIPS TOMOSCAN SR 4000. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on October 11, 1994 after a review of 285 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 North America, Inc. devices

Submission Details

510(k) Number K936272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1993
Decision Date October 11, 1994
Days to Decision 285 days
Submission Type Traditional
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
178d slower than avg
Panel avg: 107d · This submission: 285d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 604
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K936272.
ANATOM 2000
K944131 · Analogic Corp. · Jan 1995
MEDRAD COUNTERPOISE SYSTEM
K944983 · Medrad, Inc. · Nov 1994
PHILIPS TOMOSCAN SR5000
K944326 · Philips Medical Systems North America, Inc. · Oct 1994
SOMATOM PROJECT 059
K941546 · Siemens Corp. · Sep 1994
HISPEED ADVANTAGE II
K940606 · GE Medical Systems · Aug 1994
ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW
K932508 · Elscint, Inc. · Jul 1994