DEVICE: InfiMed Precision MPi, RF, CCD Camera (00858086006078)
Device Identifier (DI) Information
InfiMed Precision MPi, RF, CCD Camera
Precision MPi RF
Not in Commercial Distribution
INFIMED, INC.
Precision MPi RF
Not in Commercial Distribution
INFIMED, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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No |
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? |
---|---|---|---|---|
40847 | X-ray system computer, diagnostic, general-purpose |
A dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a general-purpose medical x-ray system and associated image processing, display and analysis functions.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OWB | Interventional fluoroscopic x-ray system |
JAA | System, x-ray, fluoroscopic, image-intensified |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
ff92bbe6-fdb8-4ace-8375-88585140768b
December 09, 2019
3
September 16, 2016
December 09, 2019
3
September 16, 2016
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