DEVICE: SRS MR Adapter (10841962110775)

Device Identifier (DI) Information

SRS MR Adapter
RT-4600-03-MRI
In Commercial Distribution
RT-4600-03-MRI
Qfix
10841962110775
GS1

1
808875397 *Terms of Use
SRS MR Adapter for Portrait™ and S-Type Devices
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Device Characteristics

MR Safe
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?
61129 Patient positioner base plate
A device in the form of a non-mirrored flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices (not included) can be attached [e.g., arch frame, thermoplastic mask, headrest, head positioner]. It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IYE Accelerator, Linear, Medical
LNH System, Nuclear Magnetic Resonance Imaging
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
KPS System, Tomography, Computed, Emission
JAK System, X-Ray, Tomography, Computed
JAI Couch, Radiation Therapy, Powered
LHN System, Radiation Therapy, Charged-Particle, Medical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

307b8459-cdf8-42eb-9086-64a84ea2456e
March 18, 2025
4
March 04, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
610-268-0585
Compliance@qfix.com
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