510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111791Substantially Equivalent

Lumagem Molecular Breast Imaging System

Gamma Medica-Ideas Incorporated, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111791 is the FDA 510(k) clearance record for LUMAGEM MOLECULAR BREAST IMAGING SYSTEM, a class I device, cleared for Gamma Medica-Ideas Incorporated on under FDA product code IYX (Camera, Scintillation (Gamma)). FDA records list 2 510(k) clearances for Gamma Medica-Ideas Incorporated, from to . As of , FDA records show no recalls naming K111791.

Clearance record

Decision date
Received
(88 days to decision)
Product code
IYX Camera, Scintillation (Gamma)
Regulation
21 CFR 892.1100
Device class
Class I
Review panel
Radiology
Applicant
Gamma Medica-Ideas Incorporated 755 N Mathilda Ave., Sunnyvale CA
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