RapidCheck

GUDID B136RC10000

The RapidCHECK platform is intended for supporting users in analyzing diagnostic imaging data to ensure the performance of the diagnostic system is op

GAMMEX, INC.

Multidisciplinary medical image management software Multidisciplinary medical image management software

• Primary Device ID: B136RC10000
• NIH Device Record Key: ccbf4c53-df67-4eca-bcb1-f0e577631f2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RapidCheck
• Version Model Number: RC1000
• Company DUNS: 157308230
• Company Name: GAMMEX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-232-9699
• Email: GlobalSupport@sunnuclear.com
• Phone: 800-232-9699
• Email: GlobalSupport@sunnuclear.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B136RC10000 [Primary]

FDA Product Code

• LHO: Instrument, Quality-Assurance, Radiologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-31
• Device Publish Date: 2018-11-28

Devices Manufactured by GAMMEX, INC.

• B136159A0 - Phototimer Consistency Tools: 2021-12-09
• B1361150 - Sun Nuclear 115A Half Value Layer Attenuator Set: 2021-09-06
• B136115H0 - Sun Nuclear 115H Half Value Layer Attenuator Set: 2021-09-06
• B13614640 - Sun Nuclear Advanced iqModule: 2021-09-06
• B13614670 - Sun Nuclear Advanced Electron Density Phantom: 2021-09-06
• B13614720 - Sun Nuclear Multi-Energy CT Phantom: 2021-09-06
• B136159ABR0 - Sun Nuclear Phototimer Consistency Tools: 2021-09-06
• B1362000 - Sun Nuclear Low Contrast Test Tool: 2021-09-06