Cleared Traditional

K964167 - DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)

K964167 is an FDA 510(k) clearance for DECISION SUPPORT SYSTEM (FOR RADIATION ..., manufactured by Multidata Systems International Corp.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K964167 · Multidata Systems International Corp. · Radiology device
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Mar 1997
Decision
156d
Days
Class 2
Risk

K964167 is an FDA 510(k) clearance for the DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY). Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Multidata Systems International Corp. (St. Louis, US). The FDA issued a Cleared decision on March 21, 1997 after a review of 156 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 Multidata Systems International Corp. devices

FDA 510(k) Submission Details - K964167

510(k) Number K964167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1996
Decision Date March 21, 1997
Days to Decision 156 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 107d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, 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 - IYE Accelerator, Linear, Medical

All 528
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K964167.
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