510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K993813Substantially Equivalent

Lumagem Scintillation Camera

Gamma Medica, Northridge CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993813 is the FDA 510(k) clearance record for LUMAGEM SCINTILLATION CAMERA, a class I device, cleared for Gamma Medica on under FDA product code IYX (Camera, Scintillation (Gamma)). FDA records list one 510(k) clearance for Gamma Medica. As of , FDA records show no recalls naming K993813.

Clearance record

Decision date
Received
(69 days to decision)
Product code
IYX Camera, Scintillation (Gamma)
Regulation
21 CFR 892.1100
Device class
Class I
Review panel
Radiology
Applicant
Gamma Medica 19355 Business Center Dr., Northridge CA
510(k) summary
Summary
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