510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940539Substantially Equivalent

Stand Imaging Dose Calibrator Shielded Work Platform

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

K940539 is the FDA 510(k) clearance record for STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM, a class I device, cleared for Standard Imaging, Inc. on under FDA product code KPY (Shield, Protective, Personnel). FDA records list 10 510(k) clearances for Standard Imaging, Inc., from to . As of , FDA records show no recalls naming K940539.

Clearance record

Decision date
Received
(37 days to decision)
Product code
KPY Shield, Protective, Personnel
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Standard Imaging, Inc. 6213 Middleton Springs Dr.,, Middleton WI
510(k) summary
Statement
Third party review
No

Clearances, product code KPY

Trailing 12 months

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

FDA records show no clearances under product code KPY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPY, 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