510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K010417Substantially Equivalent

Cal/rad Mark IV-Dose Calibrator 34-162 Veenstra Model # Vdc-304

Nuclear Assoc., Div. Inovision LP, Carle Place NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010417 is the FDA 510(k) clearance record for CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304, a class II device, cleared for Nuclear Assoc., Div. Inovision LP on under FDA product code KPT (Calibrator, Dose, Radionuclide). FDA records list one 510(k) clearance for Nuclear Assoc., Div. Inovision LP. As of , FDA records show no recalls naming K010417.

Clearance record

Decision date
Received
(73 days to decision)
Product code
KPT Calibrator, Dose, Radionuclide
Regulation
21 CFR 892.1360
Device class
Class II
Review panel
Radiology
Applicant
Nuclear Assoc., Div. Inovision LP 100 Voice Rd., Carle Place NY
510(k) summary
Statement
Third party review
No

Clearances, product code KPT

Trailing 12 months

FDA records hold no clearances under product code KPT in the trailing twelve months.

FDA records show no clearances under product code KPT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260