- Physicians Office Resource

SRC PHANTOM CS 20-2 GE68 2 MCI PLYU - 10239097

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

Special Storage Condition, Specify

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: IYQ

Device Name: Phantom, Flood Source, 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: 892.1380

Third Party Flag: N

Medical Specialty: RA

Device Identifiers

Device Id: 04056869002583

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

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