Cleared Traditional

K850815 - RADIOISOTOPE CALIBRATOR MODEL 34-062 (FDA 510(k) Clearance)

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

K850815 · Victoreen, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
174d
Days
Class 2
Risk

K850815 is an FDA 510(k) clearance for the RADIOISOTOPE CALIBRATOR MODEL 34-062. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Victoreen, Inc. (Carle Place, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 174 days - an extended review cycle.

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 K850815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1985
Decision Date August 21, 1985
Days to Decision 174 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 107d · This submission: 174d
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.