Identity
- Trade Name
- InReach EUDAMEDIn Reach FDA UDI
- Generic Name
- Limited-view-field CT system FDA UDI
- Device Name
- HiRise EUDAMEDCone 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. FDA UDI
- Model / Reference
- 1040 EUDAMED1020 EUDAMED1020-230 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863152000331 EUDAMEDFDA UDI
- Basic UDI-DI
- 8631520003CBCTDevicesCL EUDAMED
- Direct Marketing DI
- 00863152000331 EUDAMED
- 510(k) Number
- K170789 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030699 COMPUTED TOMOGRAPHS (CT) - OTHER EUDAMED
- GMDN Term
- Limited-view-field CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
InReach by CurveBeam LLC — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170789 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 8631520003CBCTDevicesCL | Class IIb | Active |
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Manufacturer
- Manufacturer
- CurveBeam LLC
- EUDAMED SRN
- US-MF-000004033
- Authorised Representative
- ea-services FR-AR-000003449
Sources (3)
- EUDAMED f9873ca2-ab49-4bb0-afb2-8777992c321b 61 fields · synced Jun 19, 2026
- FDA UDI 6e487f56-5787-4210-8a5b-034b274b90ae 34 fields · synced May 30, 2026
- FDA 510(k) K170789 1 fields · synced May 18, 2026