Aptima BV Assay; Aptima CV/TV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED QDR-1000 X-RAY BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

FDA 510(k)

FDA Class 2 ·Microbiology

Genius AI Detection 2.0

FDA 510(k)

FDA Class 2 ·Radiology

ProFlu+ Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima® Chlamydia trachomatis Assay

FDA 510(k)

FDA Class 1 ·Microbiology

Panther Fusion AdV/hMPV/RV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima Trichomonas vaginalis Assay

FDA 510(k)

FDA Class 2 ·Immunology

QUANTRA

FDA 510(k)

FDA Class 2 ·Radiology

PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

IVA (MXA II SOFTWARE OPTION)

FDA 510(k)

FDA Class 2 ·Radiology

APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS

FDA 510(k)

FDA Class 2 ·Radiology

MAMMOSITE CAVITY EVALUATION DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

Unifi Workspace v1.0.0

FDA 510(k)

FDA Class 2 ·Radiology

INVADER MTHFR 1298

FDA 510(k)

FDA Class 2 ·Hematology

FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

FDA 510(k)

FDA Class 2 ·Radiology

MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NHANES WHOLE BODY DXA REFERENCE DATABASE

FDA 510(k)

FDA Class 2 ·Radiology

Affirm Contrast Biopsy

FDA 510(k)

FDA Class 2 ·Radiology