Cleared Traditional

SYNTEX SYSTEM 6000 (K761330) - FDA 510(k) Clearance

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

K761330 · Syntex Corp. · Radiology device
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Dec 1976
Decision
3d
Days
Class 2
Risk

K761330 is an FDA 510(k) clearance for the SYNTEX SYSTEM 6000. 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 December 30, 1976 after a review of 3 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 Syntex Corp. devices

Submission Details

510(k) Number K761330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1976
Decision Date December 30, 1976
Days to Decision 3 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 107d · This submission: 3d
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 421
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K761330.
CT/T SYSTEM MODEL B7800A
K772317 · General Electric Co. · Jan 1978
TOMOGRAPHIC SYSTEM, COMPUTERIZED
K772123 · Philips Medical Systems (Cleveland), Inc. · Nov 1977
SYNERVIEW MODEL 6478
K770855 · Philips Medical Systems (Cleveland), Inc. · May 1977
CT/N-II SCANNER SYSTEM
K760688 · General Electric Co. · Oct 1976