DEVICE: Pentacam (04049584000019)
Device Identifier (DI) Information
Pentacam
70700
In Commercial Distribution
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
70700
In Commercial Distribution
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take
photographs of the anterior segment of the eye, table mounted and AC powered. The system
is based on the Scheimpflug Principle for Slit Image photography. The device consists of a
measurement unit, power supply and a CPU. The measuring system uses blue light (UV-free)
given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuring
system offers the possibility of automatically rotation to get photographs of every part of the
eye. The system calculates from the photos a 3D-model1 of the eye.
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. 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? |
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18038 | Corneal topography system |
An assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MXK | Device,Analysis,Anterior Segment |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K030719 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 10.5 Kilogram |
Height: 535 Millimeter |
Depth: 360 Millimeter |
Width: 280 Millimeter |
Device Record Status
287d4203-6f29-4cc5-9007-7157e65177f8
July 06, 2018
3
September 01, 2016
July 06, 2018
3
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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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
[?]
No Customer Contact currently defined