510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K002833Substantially Equivalent

Modification to Standard Imaging Pt 1000 Ion Chamber

Standard Imaging Inc., Middleton WI / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K002833 is the FDA 510(k) clearance record for MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER, a class II device, cleared for Standard Imaging, Inc. on under FDA product code KPT (Calibrator, Dose, Radionuclide). FDA records list 10 510(k) clearances for Standard Imaging, Inc., from to . As of , FDA records show no recalls naming K002833.

Clearance record

Decision date
Received
(16 days to decision)
Product code
KPT Calibrator, Dose, Radionuclide
Regulation
21 CFR 892.1360
Device class
Class II
Review panel
Radiology
Applicant
Standard Imaging, Inc. 7601 Murphy Dr., Middleton WI
510(k) summary
Summary
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