Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope
Summary
Nidek Co., Ltd. received 510(k) clearance for Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX, a OBO device. Cleared on 2023-03-30.
Details
Source
510(k) Clearance
External ID
K221320
Action Date
2023-03-30
Status
Traditional
Category
device
Product Code
OBO
Product Description
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX. Product code: OBO.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Nidek Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Nidek Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K221320" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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