Identity
- Trade Name
- AL-Scan Viewer for NAVIS-EX FDA UDI
- Generic Name
- Eye anterior segment analyser software FDA UDI
- Device Name
- The AL-Scan Viewer for NAVIS-EX software (hereafter referred to as AL-Scan Viewer) is used to handle the AL-Scan data within NAVIS-EX. This function is added to the computer as a plug-in for NAVISEX. The measured value data and waveform can be displayed, the IOL power can be calculated, and the toric lens assist data can be created. The AL-Scan data is imported to NAVIS-EX using separate software, Data Acquisition Service. FDA UDI
- Model / Reference
- 1.1 FDA UDI
- Description
- The AL-Scan Viewer for NAVIS-EX software (hereafter referred to as AL-Scan Viewer) is used to handle the AL-Scan data within NAVIS-EX. This function is added to the computer as a plug-in for NAVISEX. The measured value data and waveform can be displayed, the IOL power can be calculated, and the toric lens assist data can be created. The AL-Scan data is imported to NAVIS-EX using separate software, Data Acquisition Service. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101360 FDA UDI
- FDA Product Code
- NFJ FDA UDI
- GMDN Term
- Eye anterior segment analyser software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Eye anterior segment analyser software
AL-Scan Viewer for NAVIS-EX by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eye anterior segment analyser software.
- ANTERION — Heidelberg Engineering · Class II
- Image filing software NAVIS-EX — Nidek, Inc. · Class I
- AL-Scan Viewer for NAVIS-EX — Nidek, Inc. · Class II
- Data Acquisition Service for NAVIS-EX — Nidek, Inc. · Class II
- CEM Viewer for NAVIS-EX — Nidek, Inc. · Class II
- CEM Viewer for NAVIS-EX — Nidek, Inc. · Class II
- Image filing software — Nidek, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA UDI 04ac155c-4c48-4cf0-86e4-fa612e409eea 34 fields · synced Jun 8, 2026