ASM SRC LS-HR+ LINE SRCS - 10223322
Device Description
A device that includes a wide variety of two or three-dimensional (3-D) phantoms used in both calibration protocols and in subjective and quantitative evaluations of the performance of diagnostic nuclear medicine (NM) detector systems, e.g., gamma cameras, single photon emission computed tomography (SPECT), positron emission tomography (PET) or associated image display system and software programs. It consists of either fixed or variable configurations or patterns of absorbing or attenuating materials and radioactive source holders. The design can incorporate radioactive sealed sources or refillable radioactive source wells to which radioactivity can be added.
Environmental Conditions
- Radioactive sources should be stored in a designated area which is secure & provides adequate shielding.Records which conform to local regulatory requirements are required for all radioactive sources.
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: IXD
Device Name: Source, Calibration, Sealed, Nuclear
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: RA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 892.1400
Third Party Flag: N
Medical Specialty: RA
Device IdentifiersDevice Id: 04056869002644
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A