PedCAT

Primary DI
00863152000317
Brand
PedCAT
Company
CURVEBEAM, LLC
Model
1000-230
Device description
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.
Published
2017-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113548000PEDCATCurvebeam, LLC2012-04-10JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863152000317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863152000317008631520003178631520003170863152000317

GMDN Terms#

Term, Definition table
TermDefinition
Limited-view-field CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices having a gantry whose design limits its use to head and neck and/or extremity imaging applications. Included are single or multiple fixed annular arrays of x-ray tubes and opposing detectors or x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
068780729
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863152000362CubeVue 3.6.02018-09-10
00863152000379CubeVue 3.7.02018-09-26
00860004550020HiRise1040-1152021-01-20
00860004550037HiRise1040-2302021-01-20
00863152000348LineUP1030-1152018-09-10
00863152000355LineUP1030-2302018-09-10
00863152000300PedCAT1000-1152017-08-01
00863152000324In Reach1020-1152017-08-01
00863152000331In Reach1020-2302017-08-01

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