CURVEBEAM, LLC

Address:2800 Bronze Dr.,Hatfield,PA,19440,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, X-Ray, Tomography, Computed (JAK) (8) System, Image Processing, Radiological (LLZ) (2)

Premarket Exempt

Clear

HiRise - 00860004550020 Catalog Number :

Device Description : CBCT upper & lower extremities including the pelvis

Device Class : 2

Duns Number: 068780729

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

HiRise - 00860004550037 Catalog Number :

Device Description : CBCT upper & lower extremities including the pelvis

Device Class : 2

Duns Number: 068780729

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

PedCAT - 00863152000300 Catalog Number :

Device Description : Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot an 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.

Device Class : 2

Duns Number: 068780729

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

PedCAT - 00863152000317 Catalog Number :

Device Description : Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot an 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.

Device Class : 2

Duns Number: 068780729

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

In Reach - 00863152000324 Catalog Number :

Device Description : Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible wi 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.

Device Class : 2

Duns Number: 068780729

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

In Reach - 00863152000331 Catalog Number :

Device Description : Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible wi 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.

Device Class : 2

Duns Number: 068780729

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

LineUP - 00863152000348 Catalog Number :

Device Description : Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of upper extremities.

Device Class : 2

Duns Number: 068780729

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

LineUP - 00863152000355 Catalog Number :

Device Class : 2

Duns Number: 068780729

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

CubeVue - 00863152000362 Catalog Number :

Device Description : 3D visualization software

Device Class : 2

Duns Number: 068780729

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

CubeVue - 00863152000379 Catalog Number :

Device Description : 3D visualization software

Device Class : 2

Duns Number: 068780729

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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