Cleared Traditional

PHILIPS TOMOSCAN SR (K912752) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912752 · Philips Medical Systems North America, Inc. · Radiology device
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Sep 1991
Decision
77d
Days
Class 2
Risk

K912752 is an FDA 510(k) clearance for the PHILIPS TOMOSCAN SR. 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 September 6, 1991 after a review of 77 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 K912752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1991
Decision Date September 06, 1991
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
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 379
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K912752.
CT SYTEC 8000
K913485 · General Electric Co. · Jan 1992
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K913996 · Siemens Medical Solutions USA, Inc. · Nov 1991
KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE
K912454 · Eastman Kodak Company · Sep 1991
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM
K910859 · Siemens Medical Solutions USA, Inc. · May 1991
CT SYTEC 4000
K911387 · GE Medical Systems · May 1991
CT HILIGHT ADVANTAGE II
K904971 · GE Medical Systems · Jan 1991