510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780736Substantially Equivalent

CT 5221 Dose Reducing Collimators

Emi Medical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780736 is the FDA 510(k) clearance record for CT 5221 DOSE REDUCING COLLIMATORS, a class II device, cleared for Emi Medical, Inc. on under FDA product code IZX (Collimator, Manual, Radiographic). FDA records list 13 510(k) clearances for Emi Medical, Inc., from to . As of , FDA records show no recalls naming K780736.

Clearance record

Decision date
Received
(32 days to decision)
Product code
IZX Collimator, Manual, Radiographic
Regulation
21 CFR 892.1610
Device class
Class II
Review panel
Radiology
Applicant
Emi Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IZX

Trailing 12 months

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

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