DEVICE: Xstrahl 200 X-Ray System - Floor (05060494200046)
Device Identifier (DI) Information
Xstrahl 200 X-Ray System - Floor
Xstrahl 200 X-Ray System - Floor
In Commercial Distribution
XSTRAHL LIMITED
Xstrahl 200 X-Ray System - Floor
In Commercial Distribution
XSTRAHL LIMITED
Xstrahl 200 X-Ray System - Floor
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
59233 | Stationary orthovoltage therapeutic x-ray system |
An assembly of devices designed to produce low-energy x-rays used for therapeutic purposes, primarily in the treatment of skin cancer (e.g., basal cell or squamous cell carcinoma) or other skin conditions (e.g., psoriasis, keloid). The radiation source typically uses a tube voltage of between approximately 100 kV and 500 kV and will be used in conjunction with a variety of topical applicators. The main system is ceiling- or wall-mounted (fixed) in a radiotherapy suite or other clinical setting.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JAD | System, Therapeutic, X-Ray |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c89dcfe1-dc15-44f6-87ba-28831f210dab
March 29, 2018
2
January 27, 2017
March 29, 2018
2
January 27, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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