DEVICE: Monarch™ Software Laptop v2.1.3 (B634SW0032760201030)

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Device Record History
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Device Identifier (DI) Information
Monarch™ Software Laptop v2.1.3
Version 2.1.3
In Commercial Distribution

AURIS HEALTH, INC.
B634SW0032760201030
HIBCC

1
015823456 *Terms of Use
Monarch™ Software Laptop v2.1.3
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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?
40867 CT system application software
An application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and version or upgrade number.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EOQ Bronchoscope (Flexible Or Rigid)
JAK System, X-Ray, Tomography, Computed
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K173760 000
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
9b51a091-cfbf-4817-9dcd-fb820f39748a
November 15, 2018
1
October 15, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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