Lumagem Molecular Breast Imaging System

Q: What is the product code of K111791?

The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.

FDA 510(k) K111791 · Gamma Medica-Ideas Incorporated

Substantially Equivalent

510(k) numberK111791

Submission

Device name: Lumagem Molecular Breast Imaging System
Applicant: Gamma Medica-Ideas Incorporated
Sunnyvale, CA, US
Received: June 27, 2011
Decision date: September 23, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: IYX – Camera, Scintillation (Gamma)
Device class: Class I (low risk)
Regulation: 21 CFR 892.1100
Specialty: Radiology

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K160933	Discovery NM 750b BopsyIYX · Traditional	GE Healthcare	11/18/2016SE
K162052	Sentinella 102, Sentinella 102 HorusIYX · Special	General Equipment For Medical Imaging (Oncovision-	08/18/2016SE
K143156	Sentinella 102; Sentinella 102 HorusIYX · Traditional	General Equipment For Medical Imaging (Oncovision-	11/18/2014SE
K123408	Ergo Imaging SystemIYX · Traditional	Digirad Corp.	01/15/2013SE
K110384	Dilon 6800 Acella (Acella)IYX · Traditional	Dilon Technologies, Inc.	05/03/2011SE
K110601	Sentinella 102IYX · Traditional	General Equipment For Medical Imaging, S.A.	03/18/2011SE
K102231	Discovery NM 750BIYX · Traditional	Ge Medical Systems Israel, Functional Imaging	11/03/2010SE

More from Ge Medical Systems Israel, Functional Imaging

510(k)	Device	Decision
K111731	Molecular Breast Imaging SoftwareLLZ · Traditional	09/15/2011SE

Questions and answers

When was Lumagem Molecular Breast Imaging System cleared by the FDA?

Lumagem Molecular Breast Imaging System (K111791) received a 510(k) decision of Substantially Equivalent on September 23, 2011, 88 days after the submission was received.

What is the product code of K111791?

The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.