Cleared Traditional

K761033 - COMPUTERIZED TOMOGRAPHY SCANNER

K761033 is an FDA 510(k) clearance for COMPUTERIZED TOMOGRAPHY SCANNER, manufactured by Syntex Corp.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K761033 · Syntex Corp. · Radiology device
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Nov 1976
Decision
9d
Days
Class 2
Risk

K761033 is an FDA 510(k) clearance for the COMPUTERIZED TOMOGRAPHY SCANNER. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Syntex Corp. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1976 after a review of 9 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.

FDA 510(k) Submission Details - K761033

510(k) Number K761033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1976
Decision Date November 24, 1976
Days to Decision 9 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 107d · This submission: 9d
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 826
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K761033.
ACTA-SCANNER R 0200FS
K770573 · Pfizer Medical Systems, Inc. · Mar 1977
SYNTEX SYSTEM 6000
K761330 · Syntex Corp. · Dec 1976
HI-SENSITIVITY MODE OPTION FOR S60-1A
K761332 · Syntex Corp. · Dec 1976
GE CT/T MODEL NO. B7800 A
K760882 · Arnold & Porter For G.E. Co. · Nov 1976
PHO. TRAX MODEL 4000 WHOLE BODY SCAN.
K760808 · G.D. Searle and Co. · Nov 1976
X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC
K760201 · American Science and Engineering, Inc. · Oct 1976
K761033 · COMPUTERIZED TOMOGRAPHY SCANNER
Download PDF Syntex Corp.