Search Results
Found 1 results
510(k) Data Aggregation
K Number
K081757Device Name
VERISTA IMAGING ISOCAM II GAMMA CAMERA
Manufacturer
Date Cleared
2008-08-15
(56 days)
Product Code
Regulation Number
892.1100Why did this record match?
Applicant Name (Manufacturer) :
VERISTA IMAGING INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Verista Imaging ISOCAM II Gamma Camera is intended to image the distribution of radionuclides in the body by means of photon radiation detector(s).
Device Description
The ISOCAM II Gamma Camera is a medical imaging device used in nuclear medicine. It produces gamma ray distribution emitting radionuclides. It consists of one or more detectors mounted on a gantry that is connected to an acquisition system for operating the camera and storing the images. The base unit is a nuclear imaging device which utilizes gamma ray scintillation technologies. The modification to the device is limited to an upgrade to the mechanical operation of the device. The modifications improve patient safety through changes to the arm drive mechanical components and the addition of a weighted counter balance system.
Ask a Question
Ask a specific question about this device
Page 1 of 1