PDS PLATES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit

FDA 510(k)

FDA Class 2 ·Radiology

aetherSlide

FDA 510(k)

FDA Class 2 ·Pathology

BR-FHUS Navigation 1.0

FDA 510(k)

FDA Class 2 ·Radiology

ECG Acquisition Systems

FDA 510(k)

FDA Class 2 ·Cardiovascular

BR-FHUS Viewer 1.0

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow

FDA 510(k)

FDA Class 2 ·Radiology

TOMi Scope

FDA 510(k)

FDA Class 2 ·Radiology

OtoSight Middle Ear Scope

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL

FDA 510(k)

FDA Class 2 ·Radiology

Catheter, Steerable

FDA classification

FDA Class 2 ·Catheter, Steerable

Hearing Aid, Air Conduction, Transcutaneous System

FDA classification

FDA Class 2 ·Hearing Aid, Air Conduction, Transcutaneous System

Oximeter, Ear

FDA classification

FDA Class 2 ·Oximeter, Ear

Device System, Imaging, Tympanic Membrane And Middle Ear

FDA classification

FDA Class 2 ·Device System, Imaging, Tympanic Membrane And Middle Ear

Thermal Vestibular Stimulator For Headache

FDA classification

FDA Class 2 ·Thermal Vestibular Stimulator For Headache

Prosthesis, Ear, Internal

FDA classification

FDA Class 2 ·Prosthesis, Ear, Internal

Mold, Middle-Ear

FDA classification

FDA Class 2 ·Mold, Middle-Ear

Eia, Blastomyces Dermatitidis

FDA classification

FDA Class 2 ·Eia, Blastomyces Dermatitidis

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNETOM