PedCAT

GUDID 00863152000317

Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot and ankle. Compatible with 230 Volts power outlet. 3D field of view of 20 cm (height) x 35 cm (diameter) accommodates weight bearing, bilateral imaging of both entire feet/ankles. Built-in cushioned seat allows for non-weight bearing imaging. Handlebars assist patients with entry into and exit from device. Scan time is 48 seconds or less. Scans are output as DICOM compatible 3D reconstructions, 0.3 mm multi-planar slices. PedCAT system includes acquisition station and visualization station enabled with CubeVue visualization software.

CURVEBEAM, LLC

Limited-view-field CT system

• Primary Device ID: 00863152000317
• NIH Device Record Key: 97234c90-7509-49e0-a0f5-a9f77b94993a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PedCAT
• Version Model Number: 1000-230
• 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: false
• 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	00863152000317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113548

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 [PedCAT]

• 00863152000317: Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot and ankle. Compati
• 00863152000300: Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot and ankle. Compati