DEVICE: See Factor CT3 (00860012510900)
Device Identifier (DI) Information
See Factor CT3
9801101000
In Commercial Distribution
EPICA HUMAN HEALTH LLC
9801101000
In Commercial Distribution
EPICA HUMAN HEALTH LLC
Mobile multimodality cone beam computed tomography scanner.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61019 | Cone beam computed tomography system, head/neck |
A stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OWB | Interventional Fluoroscopic X-Ray System |
JAK | System, X-Ray, Tomography, Computed |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K233230 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e01542b4-062b-4b0c-9042-6cb1abc19831
September 17, 2024
1
September 09, 2024
September 17, 2024
1
September 09, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined