Cleared Traditional

K944326 - PHILIPS TOMOSCAN SR5000

K944326 is the FDA 510(k) clearance for PHILIPS TOMOSCAN SR5000 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 53-day FDA review.

K944326 · Philips Medical Systems North America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
53d
Days
Class 2
Risk

K944326 is an FDA 510(k) clearance for the PHILIPS TOMOSCAN SR5000. 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 21, 1994 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Medical Systems North America, Inc. devices

Submission Details

510(k) Number K944326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1994
Decision Date October 21, 1994
Days to Decision 53 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
54d faster than avg
Panel avg: 107d · This submission: 53d
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 K944326.
CT PROSPEED FAMILY
K944013 · GE Medical Systems · Feb 1995
ANATOM 2000
K944131 · Analogic Corp. · Jan 1995
MEDRAD COUNTERPOISE SYSTEM
K944983 · Medrad, Inc. · Nov 1994
PHILIPS TOMOSCAN SR 4000
K936272 · 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