Cleared Traditional

K030066 - CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165

K030066 is an FDA 510(k) clearance for CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, manufactured by Nuclear Associates. The device is a Class 2 Radiology device with product code KPT cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K030066 · Nuclear Associates · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
234d
Days
Class 2
Risk

K030066 is an FDA 510(k) clearance for the CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Nuclear Associates (Hicksville, US). The FDA issued a Cleared decision on August 29, 2003 after a review of 234 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 Nuclear Associates devices

FDA 510(k) Submission Details - K030066

510(k) Number K030066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2003
Decision Date August 29, 2003
Days to Decision 234 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 107d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPT Device Classification - Class 2, Special Controls

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

All 8
Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K030066.
CRC PC Smart Chamber K1
K192199 · Capintec, Inc. · Sep 2019
Veenstra Instruments VDC-506 Dose Calibrator
K142325 · Comecer Netherlands B.V. · Sep 2014
CRC PC WITH SMART CHAMBER
K141413 · Capintec, Inc. · Jun 2014
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
K011493 · Mentor Corp. · Oct 2002
NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.
K931657 · Victoreen, Inc. · Jul 1993
RADIOISOTOPE CALIBRATOR MODEL 34-062
K850815 · Victoreen, Inc. · Aug 1985