In Reach

Primary DI
00863152000331
Brand
In Reach
Company
CURVEBEAM, LLC
Model
1020-230
Device description
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.
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
K170789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170789000In ReachCurvebeam, LLC2017-05-05JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863152000331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863152000331008631520003318631520003310863152000331

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
00863152000317PedCAT1000-2302017-08-01
00863152000324In Reach1020-1152017-08-01

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Primary DI, Brand, Company table
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