Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS

FDA 510(k)

FDA Class 2 ·Radiology

Aptima Combo 2 Assay (Panther System)

FDA 510(k)

FDA Class 2 ·Microbiology

DIGITAL SPOT MAMMOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”

FDA 510(k)

FDA Class 2 ·Pathology

X-CALIBER MODEL 1000 BONE MINERAL ANALYZER

FDA 510(k)

FDA Class 2 ·Radiology

HOLOGIC DR IMAGEPRO

FDA 510(k)

FDA Class 2 ·Radiology

Aptima Neisseria gonorrhoeae Assay

FDA 510(k)

FDA Class 2 ·Microbiology

HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED

FDA 510(k)

FDA Class 2 ·Radiology

HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER

FDA 510(k)

FDA Class 2 ·Radiology

HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris

FDA 510(k)

FDA Class 2 ·Microbiology

HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY

FDA 510(k)

FDA Class 2 ·Radiology

SECURVIEW DX DIAGNOSTIC WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

Panther Fusion Paraflu Assay

FDA 510(k)

FDA Class 2 ·Microbiology

MYOSURE CONTROL UNIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST

FDA 510(k)

FDA Class 2 ·Radiology

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology