DEVICE: SPECTRALIS (04059237000297)
Device Identifier (DI) Information
SPECTRALIS
SPEC-CAM-S2610
In Commercial Distribution
Heidelberg Engineering GmbH
SPEC-CAM-S2610
In Commercial Distribution
Heidelberg Engineering GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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58850 | Ophthalmic spectral-domain optical coherence tomography system |
A mobile assembly of devices designed to use near infrared (NIR) LED light aimed into the eye to acquire, process, display and save in vivo depth-resolved images of anterior and posterior ocular tissue microstructures in clinical and perioperative examination through the use of interchangeable lenses. Spectral domain optical coherence tomography (SDOCT) is intended to aid in the diagnosis and evaluation of physiologic and pathologic conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis.
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Active | false |
47952 | Scanning-laser retinal imaging system |
An assembly of electrically-powered ophthalmic instruments and digital image capturing/processing devices intended to use a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of chorioditis.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OBO | Tomography, Optical Coherence |
MYC | Ophthalmoscope,Laser,Scanning |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K121993 | 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
2aa893b4-c6f0-4d6b-b70e-56b263392fd0
April 03, 2024
6
September 24, 2016
April 03, 2024
6
September 24, 2016
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
[?]
No Customer Contact currently defined