1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION

FDA 510(k)

FDA Class 2 ·Radiology

LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

Genius AI Detection

FDA 510(k)

FDA Class 2 ·Radiology

Aptima HCV Quant Dx Assay

FDA 510(k)

FDA Class 2 ·Microbiology

HOLOGIC VISCERAL FAT SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Omni Hysteroscope, Omni Lok cervical seal

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes

FDA 510(k)

FDA Class 2 ·Microbiology

MAMMOSITE MULTI LUMEN

FDA 510(k)

FDA Class 2 ·Radiology

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INVADER MTHFR 677

FDA 510(k)

FDA Class 2 ·Hematology

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

FDA 510(k)

FDA Class 2 ·Microbiology

SINGLE ENERGY (SE) FEMUR EXAMS

FDA 510(k)

FDA Class 2 ·Radiology

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

INVADER FACTOR V

FDA 510(k)

FDA Class 2 ·Hematology

QDR-1000 AND WITH X-RAY BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology