DEVICE: Planmed (06430035430055)
Device Identifier (DI) Information
Planmed
Sophie Classic
Not in Commercial Distribution
Planmed Oy
Sophie Classic
Not in Commercial Distribution
Planmed Oy
Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of breast cancer.
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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37630 | Stationary mammographic x-ray system, analogue |
An assembly of devices specifically designed to provide a fixed installation (in an imaging facility, or transportation van) x-ray system to compress and image the breast. It is primarily used to optimize the capability of users to visually evaluate x-ray film images representing the anatomy and function of blood and lymphatic vessels within the human breast. It uses analogue or analogue-to-digital conversion techniques for image capture and display. It is used for breast cancer screening and in conjunction with the placement of biopsy markers and stereotactic biopsy and lesion localization equipment requiring x-ray guidance.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IZH | System, X-Ray, Mammographic |
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
1ae19494-ceb5-4673-a73b-b74f694f6379
June 14, 2023
4
September 07, 2016
June 14, 2023
4
September 07, 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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined