Cleared Traditional

K924082 - PHILIPS TOMOSCAN SR7000 CT SYSTEMS

K924082 is an FDA 510(k) clearance for PHILIPS TOMOSCAN SR7000 CT SYSTEMS, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K924082 · Philips Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
209d
Days
Class 2
Risk

K924082 is an FDA 510(k) clearance for the PHILIPS TOMOSCAN SR7000 CT SYSTEMS. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on March 10, 1993 after a review of 209 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, Inc. devices

FDA 510(k) Submission Details - K924082

510(k) Number K924082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1992
Decision Date March 10, 1993
Days to Decision 209 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
102d slower than avg
Panel avg: 107d · This submission: 209d
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 K924082.
IMPAX 3000
K934832 · Heraeus Kulzer, Inc. · Dec 1993
ULTRA COMPACT VIDEO IMAGER
K930765 · International Imaging Electronics · Sep 1993
HELICAT
K930090 · Elscint, Inc. · Mar 1993
ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION
K923077 · GE Medical Systems · Feb 1993
CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM
K921192 · GE Medical Systems · Oct 1992
WRIST RESTRAINT FOR GE9800 C.T. TABLES
K923108 · Cook, Inc. · Sep 1992