R2 DIGITALNOW HD(DIGITALNOW HD)

FDA 510(k)

FDA Class 2 ·Radiology

Trident HD Specimen Radiography System

FDA 510(k)

FDA Class 2 ·Radiology

SECURVIEW DX SOFTCOPY WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

Fluent Fluid Management System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QUANTRA

FDA 510(k)

FDA Class 2 ·Radiology

INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS

FDA 510(k)

FDA Class 2 ·Radiology

THS INSTRUMENT TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

Aptima CV/TV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

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