Cleared Traditional

RPM RESPIRATORY GATING SYSTEM (K983629) - FDA 510(k) Clearance

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

K983629 · Varian Medical Systems, Inc. · Radiology device
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Jun 1999
Decision
236d
Days
Class 2
Risk

K983629 is an FDA 510(k) clearance for the RPM RESPIRATORY GATING SYSTEM. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on June 8, 1999 after a review of 236 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Medical Systems, Inc. devices

Submission Details

510(k) Number K983629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1998
Decision Date June 08, 1999
Days to Decision 236 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
129d slower than avg
Panel avg: 107d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHN System, Radiation Therapy, Charged-particle, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - LHN System, Radiation Therapy, Charged-particle, Medical

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