In Reach

GUDID 00863152000324

Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 115 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software.

CURVEBEAM, LLC

Limited-view-field CT system

• Primary Device ID: 00863152000324
• NIH Device Record Key: 8bd9d8ed-ba3d-40fc-9f60-9fd7776f0974
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In Reach
• Version Model Number: 1020-115
• Company DUNS: 068780729
• Company Name: CURVEBEAM, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863152000324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170789

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-01

On-Brand Devices [In Reach]

• 00863152000331: Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 230 Volts pow
• 00863152000324: Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 115 Volts pow