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510(k) Data Aggregation
K Number
K033199Device Name
COMPACT DIGITAL CARDIAC CAMERA (CDCC)
Manufacturer
IS2 MEDICAL SYSTEMS, INC.
Date Cleared
2003-11-12
(41 days)
Product Code
KPS, 21C
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
IS2 MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gammu ray emitting radionuctides in the body und store data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, rudionuclide unatomical markers, component parts and accessories.
To detect or image the distribution of radionuclides in the baly or organ using the following technique(s).
(a) Planar Imaging: YES, 50-250 keV
(b) Whole Body Imaging: NO
(c) Tomographic Imaging (SPECT) for non Positron emitter: YES, 50-250 keV
(d) Positron imaging by coincidence: NO
(e) Positron imaging without coincidence: NO
(f) Other indication(s) in the device label, but not included in the above list: None
Device Description
The COMPACT DIGITAL CARDIAC CAMERA nuclear imaging system has two rectangular fields of view detector heads.
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