510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944772Substantially Equivalent

Multiple Ed1600 Series Radiation Shields

Image Diagnostics, Inc., Sterling MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944772 is the FDA 510(k) clearance record for MULTIPLE ED1600 SERIES RADIATION SHIELDS, a class I device, cleared for Image Diagnostics, Inc. on under FDA product code EAK (Screen, Leaded, Operator Radiation Protector). FDA records list 3 510(k) clearances for Image Diagnostics, Inc., from to . As of , FDA records show no recalls naming K944772.

Clearance record

Decision date
Received
(23 days to decision)
Product code
EAK Screen, Leaded, Operator Radiation Protector
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Image Diagnostics, Inc. 98 Pratts Junction Rd., Sterling MA
510(k) summary
Summary
Third party review
No

Clearances, product code EAK

Trailing 12 months

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

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