510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K040587Substantially Equivalent

Mini Gamma Camera, Model Mgc-500

Acrorad Co., Ltd., Brookeville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040587 is the FDA 510(k) clearance record for MINI GAMMA CAMERA, MODEL MGC-500, a class I device, cleared for Acrorad Co., Ltd. on under FDA product code IYX (Camera, Scintillation (Gamma)). FDA records list 2 510(k) clearances for Acrorad Co., Ltd., from to . As of , FDA records show no recalls naming K040587.

Clearance record

Decision date
Received
(70 days to decision)
Product code
IYX Camera, Scintillation (Gamma)
Regulation
21 CFR 892.1100
Device class
Class I
Review panel
Radiology
Applicant
Acrorad Co., Ltd. 2305 Gold Mine Rd., Brookeville MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYX

Trailing 12 months

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

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