ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Radioimmunoassay, Amphetamine

FDA classification

FDA Class 2 ·Radioimmunoassay, Amphetamine

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

FDA classification

FDA Class 2 ·Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

NIRO-200NX

FDA 510(k)

FDA Class 2 ·Cardiovascular

P300 Attachment

FDA 510(k)

FDA Class 2 ·Neurology

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5

FDA 510(k)

FDA Class 2 ·Radiology

Estelite Universal Flow

FDA 510(k)

FDA Class 2 ·Dental

FUJIFILM Endoscope Model EG-530N

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XIDF-AWS801, Angio Workstation, V7.0

FDA 510(k)

FDA Class 2 ·Radiology

Image Filing Software NAVIS-EX

FDA 510(k)

FDA Class 2 ·Radiology

Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0

FDA 510(k)

FDA Class 2 ·Radiology

EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Applanation tonometer AT-2

FDA 510(k)

FDA Class 2 ·Ophthalmic

Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

CellChek 20 rc

FDA 510(k)

FDA Class 2 ·Radiology

12MP Color Digital Mammography LCD Monitor CL-S1200

FDA 510(k)

FDA Class 2 ·Radiology

EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER

FDA 510(k)

FDA Class 2 ·General Hospital

21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR

FDA 510(k)

FDA Class 2 ·Radiology