GAMMEX, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instrument, Quality-Assurance, Radiologic (LHO) (1) Monitor, Patient Position, Light-Beam (IWE) (1)

Premarket Exempt

No Yes

Clear

Sun Nuclear MICRO+ MR - B136MLR350MR0 Catalog Number : 805876

Device Description : The MICRO+ MR MLR+350 Laser is used for aligning patients to medical diagnostic The MICRO+ MR MLR+350 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

RapidCheck - B136RC10000 Catalog Number :

Device Description : The RapidCHECK platform is intended for supporting users in analyzing diagnostic The RapidCHECK platform is intended for supporting users in analyzing diagnostic imaging data to ensure the performance of the diagnostic system is operating within safe and expected tolerances.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

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