Cleared Traditional

K010417 - CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304

K010417 is an FDA 510(k) clearance for CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 ..., manufactured by Nuclear Assoc., Div. Inovision LP. The device is a Class 2 Radiology device with product code KPT cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K010417 · Nuclear Assoc., Div. Inovision LP · Radiology device
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Apr 2001
Decision
73d
Days
Class 2
Risk

K010417 is an FDA 510(k) clearance for the CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Nuclear Assoc., Div. Inovision LP (Carle Place, US). The FDA issued a Cleared decision on April 26, 2001 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nuclear Assoc., Div. Inovision LP devices

FDA 510(k) Submission Details - K010417

510(k) Number K010417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2001
Decision Date April 26, 2001
Days to Decision 73 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
34d faster than avg
Panel avg: 107d · This submission: 73d
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 9
Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K010417.
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B.D.A.S.
K813065 · General Electric Co. · Dec 1981