EMIT 700 CANNABINOID 20 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY

FDA 510(k)

FDA Class 2 ·Radiology

EMIT 700 METHADONE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Eclipse Treatment Planning System (18.1)

FDA 510(k)

FDA Class 2 ·Radiology

EMIT(R) II OPIATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR SYVA BARBITURATE ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VARIAN C-SERIES CLINACS (CLINAC 2300C/D)

FDA 510(k)

FDA Class 2 ·Radiology

Viz CTP

FDA 510(k)

FDA Class 2 ·Radiology

JOULE CLEARSENSE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VARIAN ELECTRONIC PORTAL IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VARIAN HIGH ENERGY LINEAR ACCELERATOR

FDA 510(k)

FDA Class 2 ·Radiology

AI Segmentation

FDA 510(k)

FDA Class 2 ·Radiology

TRANSLUMINAL ENDARTERECTOMY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARIA Radiation Therapy Management (v16.1 MR3)

FDA 510(k)

FDA Class 2 ·Radiology

SYVA SOLID PHASE COLUMNS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMIT QST CARBAMAZEPINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER

FDA 510(k)

FDA Class 2 ·Radiology