SW upgrade, v8.0 SCA

SW upgrade, v8.0 SCA
RAPID - FGS-0479-01

A software program intended to be used with a video capsule endoscopy system control unit or an off-the-shelf computer to receive, display, process and/or manage (e.g., communicate, store) photographic image data from an ingested video capsule (not included), and/or to adjust capsule settings [e.g., position in the gastrointestinal (GI) tract]. It is intended for use by a healthcare professional in a clinical setting.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NEZ

Device Name: System, Imaging, Gastrointestinal, Wireless, Capsule

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

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: 876.1300

Third Party Flag: N

Medical Specialty: GU

Device Id: 07290101365006

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