Cleared Traditional

K844424 - INDEPENDENT JAW MODE OPTION FOR VARIAN ...

K844424 is the FDA 510(k) clearance for INDEPENDENT JAW MODE OPTION FOR VARIAN ... by Varian Assoc., Inc.. It is a Class 2 Radiology device (product code JAD) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K844424 · Varian Assoc., Inc. · Radiology device
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Feb 1985
Decision
98d
Days
Class 2
Risk

K844424 is an FDA 510(k) clearance for the INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on February 21, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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 Varian Assoc., Inc. devices

Submission Details

510(k) Number K844424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1984
Decision Date February 21, 1985
Days to Decision 98 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
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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 - JAD System, Therapeutic, X-ray

All 15
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K844424.
VERIDOSE V (FIVE), MODEL NUMBER 37-705
K964952 · Victoreen, Inc. · Jul 1997
INSTA-FLO
K935209 · Medtec, Inc. · Dec 1993
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K903377 · Siemens Medical Solutions USA, Inc. · Sep 1990
RTP-5100-5200-5300 & 5400
K833560 · Adac Laboratories · Dec 1983
RTP-5000
K813439 · Adac Laboratories · Jan 1982