System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3

FDA 510(k)

FDA Class 2 ·Radiology

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

FDA 510(k)

FDA Class 2 ·Radiology

Rover

FDA 510(k)

FDA Class 2 ·Radiology

ELECTRO-GEL

FDA 510(k)

FDA Class 2 ·Neurology

ELECTRO-CAP SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

FDA 510(k)

FDA Class 2 ·Radiology

CFR QUANT

FDA 510(k)

FDA Class 2 ·Radiology

HeartSee

FDA 510(k)

FDA Class 2 ·Radiology

ANALYST, MODEL DSP 300

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC

FDA 510(k)

FDA Class 2 ·Orthopedic

LABSONICS MAMM-O-MATE MODEL NO. 918084-1

FDA 510(k)

FDA Class 2 ·Radiology

MODEL FEL5100 FLOOR LIGHT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ICT

FDA 510(k)

FDA Class 2 ·Radiology

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

FDA 510(k)

FDA Class 2 ·Radiology

HyPHo Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

FDA 510(k)

FDA Class 2 ·Neurology

IMRIS ONCOLOGY PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

Envision 3D: Image Guidance System

FDA 510(k)

FDA Class 2 ·Neurology

FLASH EVD System (10-0002)

FDA 510(k)

FDA Class 2 ·Neurology