Cleared Traditional

K931657 - NUCLEAR ASSOCIATES MODEL 34-070 BRACHYT...

K931657 is the FDA 510(k) clearance for NUCLEAR ASSOCIATES MODEL 34-070 BRACHYT... by Victoreen, Inc.. It is a Class 2 Radiology device (product code KPT) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K931657 · Victoreen, Inc. · Radiology device
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Jul 1993
Decision
113d
Days
Class 2
Risk

K931657 is an FDA 510(k) clearance for the NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Victoreen, Inc. (Cleveland, US). The FDA issued a Cleared decision on July 27, 1993 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1360 - 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 K931657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1993
Decision Date July 27, 1993
Days to Decision 113 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
6d slower than avg
Panel avg: 107d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPT Calibrator, Dose, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1360
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 - KPT Calibrator, Dose, Radionuclide

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