HiRise (1040-230)
Curvebeam, LLC
CurveBeam, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009543051 | 3009543051 | CurveBeam, LLC | 1 | N | 2026-01-01 | 2800 Bronze Dr. STE#110 Hatfield PA US 19440 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 140516 | 1061862650 | K241713 | HiRise (1040-230) | JAK | 2024-07-12 |
| 140516 | 1350009188 | K203187 | HiRise | JAK | 2020-11-18 |
| 140516 | 1021146224 | K181962 | CubeVue | LLZ | 2018-08-07 |
| 140516 | 1304583169 | K180727 | LineUp | JAK | 2018-05-11 |
| 140516 | 1702365570 | K170789 | In Reach | JAK | 2017-05-05 |
| 140516 | 1029559605 | K113548 | PEDCAT | JAK | 2012-04-10 |
Product Codes Associated With Registrations#
PMN#
GUDID#
CubeVue - 3D visualization software
2018-09-10
CubeVue - 3D visualization software
2018-09-26
HiRise - CBCT upper & lower extremities including the pelvis
2021-01-20
HiRise - CBCT upper & lower extremities including the pelvis
2021-01-20
LineUP - Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of upper extremities.
2018-09-10
LineUP - Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of upper extremities.
2018-09-10
PedCAT - Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot and ankle. Compatible with 115 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.
2017-08-01
PedCAT - 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.
2017-08-01
In Reach - 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.
2017-08-01
In Reach - Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 230 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.
2017-08-01