RESUBMITTED ISG 3DMV WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

VISUWELL REAGIN TEST 960 TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)

FDA 510(k)

FDA Class 2 ·Microbiology

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

FDA 510(k)

FDA Class 2 ·Microbiology

QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Solana HSV 1+2/VZV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m HSV 1 & 2 / VZV

FDA 510(k)

FDA Class 2 ·Microbiology

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO

FDA 510(k)

FDA Class 2 ·Radiology

ALLEGRO VIEWING WAND

FDA 510(k)

FDA Class 2 ·Radiology

CEDARA WEBACCESS, MODEL: 2.4

FDA 510(k)

FDA Class 2 ·Radiology

ISG FAMILY OF VIEWING WANDS

FDA 510(k)

FDA Class 2 ·Neurology

DRI SLEEPER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ISG VIEWING WAND

FDA 510(k)

FDA Class 2 ·Neurology

ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)

FDA 510(k)

FDA Class 2 ·Radiology

SNN SCOUT

FDA 510(k)

FDA Class 2 ·Neurology

PIPER, MODEL NUMBER UDS-PIPERB

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology