DEVICE: HDR X-ray Source 2.2 (00858012005281)
Device Identifier (DI) Information
HDR X-ray Source 2.2
720684
In Commercial Distribution
S7501
Icad, Inc.
720684
In Commercial Distribution
S7501
Icad, Inc.
Axxent HDR X-Ray Source 25 cm HUT
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
59678 | Intraoperative/postoperative therapeutic x-ray system x-ray source |
A mains electricity (AC-powered) electronic component of an intraoperative/postoperative therapeutic x-ray system designed to generate the x-ray radiation for use primarily in the treatment of cancer (e.g., breast, brain, skin), typically during or after an operation for tumour resection. It uses voltages typically less than 50 kV to accelerate electrons through a drift tube onto a gold target where low energy x-ray radiation is generated and emitted isotropically. It is typically used with (covered by) various applicators for the different clinical applications, and mounted on a mobile (on wheels) floor stand.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JAD | System, Therapeutic, X-Ray |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K122951 | 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
267643aa-64a5-4a1f-8360-2f5ed938117a
July 06, 2018
3
September 20, 2016
July 06, 2018
3
September 20, 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