IntelliSpace Portal Platform

FDA 510(k)

FDA Class 2 ·Radiology

Zenition 90

FDA 510(k)

FDA Class 2 ·Radiology

dS FootAnkle Coil 8ch 1.5T

FDA 510(k)

FDA Class 2 ·Radiology

PHILIPS HERCEPTEST DIGITAL SCORE

FDA 510(k)

FDA Class 2 ·Hematology

dS Knee Coil 8ch 1.5T

FDA 510(k)

FDA Class 2 ·Radiology

XPERGUIDE

FDA 510(k)

FDA Class 2 ·Radiology

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Antigen, Inflammatory Response Marker, Sepsis

FDA classification

FDA Class 2 ·Antigen, Inflammatory Response Marker, Sepsis

Endoscopic Storage Cover

FDA classification

FDA Class 2 ·Endoscopic Storage Cover

Droplet Digital Pcr System

FDA classification

FDA Class 2 ·Droplet Digital Pcr System

Herpes Simplex Virus Nucleic Acid Amplification Assay

FDA classification

FDA Class 2 ·Herpes Simplex Virus Nucleic Acid Amplification Assay

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification

FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

FDA classification

FDA Class 2 ·System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

FDA classification

FDA Class 2 ·Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

FDA classification

FDA Class 2 ·Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test

Dna Genetic Analyzer

FDA classification

FDA Class 2 ·Dna Genetic Analyzer