DEVICE: ABSOLU (03700542625521)
Device Identifier (DI) Information
ABSOLU
ABSOLU
In Commercial Distribution
QUANTEL MEDICAL
ABSOLU
In Commercial Distribution
QUANTEL MEDICAL
The ABSolu is a high definition multifunction ophthalmic ultrasound system used for:
- Axial Length measurement of the eye by ultrasonic means;
- Implanted IOL power calculation, using the axial length measurement;
- Visualization of the interior of the eye and the orbit by A and B scans.
- ABSOLU S only: Advanced diagnostic - Standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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11389 | Ophthalmic ultrasound imaging system |
An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.
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FDA Product Code
[?]Product Code | Product Code Name |
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IYO | System, Imaging, Pulsed Echo, Ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K183414 | 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
2b4fefce-afdb-47cb-afe7-0edb42523ec0
July 17, 2019
1
July 09, 2019
July 17, 2019
1
July 09, 2019
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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+33(0)473475475
contact@quantel-medical.fr
contact@quantel-medical.fr