DEVICE: Quantaras Contour Companion (00860006956004)
Device Identifier (DI) Information
Quantaras Contour Companion
QCCv1.0.0
Not in Commercial Distribution
Quantitative Radiology Solutions LLC
QCCv1.0.0
Not in Commercial Distribution
Quantitative Radiology Solutions LLC
Automatic contouring for radiation treatment planning.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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? |
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40941 | Radiation therapy treatment planning workstation |
A freestanding image processing device that is a component of radiation therapy treatment planning configuration. It is sometimes considered to be a component of a picture archiving and communication system (PACS) or a local area network (LAN) configuration, e.g., a radiology information system (RIS) or hospital information system (HIS). It does not contain any controls for the direct operation of a radiation therapy system. It can receive and transmit data both on-line and off-line and is configured to provide the capability to remotely process, manipulate and view patient images and information used in treatment planning, record and verification.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QKB | Radiological Image Processing Software For Radiation Therapy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K203610 | 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
614d6a38-672c-41ae-a40c-14eaaf4a404e
March 11, 2022
2
September 27, 2021
March 11, 2022
2
September 27, 2021
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
[?]
(267) 244-8012
support@quantitativeradiologysolutions.com
support@quantitativeradiologysolutions.com