Cleared Traditional

K936272 - PHILIPS TOMOSCAN SR 4000

K936272 is an FDA 510(k) clearance for PHILIPS TOMOSCAN SR 4000, manufactured by Philips Medical Systems North America, Inc.. The device is a Class 2 Radiology device with 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K936272

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.

JAK Device Classification - Class 2, Special Controls

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 735
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