Cleared Traditional

K935435 - NUCLEAR ASSOC 37-08 SER

K935435 is the FDA 510(k) clearance for NUCLEAR ASSOC 37-08 SER by Victoreen, Inc.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K935435 · Victoreen, Inc. · Radiology device
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Jul 1994
Decision
261d
Days
Class 2
Risk

K935435 is an FDA 510(k) clearance for the NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Victoreen, Inc. (Cleveland, US). The FDA issued a Cleared decision on July 29, 1994 after a review of 261 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 Victoreen, Inc. devices

Submission Details

510(k) Number K935435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1993
Decision Date July 29, 1994
Days to Decision 261 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
154d slower than avg
Panel avg: 107d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 327
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