FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
K Number: K013694
·
Decision Nov 19, 2002
Classifications
1
FEI Numbers
31
Registration Numbers
32
Same Product Code
51
Applicant Total
77
Review Days
377
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Basic Information
- Device Name
- NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
- K Number
- K013694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nidek, Inc.
- Date Received
- November 7, 2001
- Decision Date
- November 19, 2002
- Product Code
- NFJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | FDA class 2 | Radiology |
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Other Clearances by Nidek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050336 | OPD-STATION SOFTWARE | Aug 24, 2005 | Substantially Equivalent |
| K042785 | MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 | Dec 14, 2004 | Substantially Equivalent |
| K031733 | NON-CONTACT TONOMETER, MODEL NT-4000 | Dec 4, 2003 | Substantially Equivalent |
| K032085 | GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 | Oct 3, 2003 | Substantially Equivalent |
| K020876 | ECHOSCAN, MODEL US-1800 | May 3, 2002 | Substantially Equivalent |
| K014274 | NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 | Apr 17, 2002 | Substantially Equivalent |
| K013760 | DC-3300 LASER DIODE PHOTOCOAGULATOR | Feb 11, 2002 | Substantially Equivalent |
| K013864 | MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 | Feb 8, 2002 | Substantially Equivalent |
| K990119 | EPI-STAR SURGICAL LASER SYSTER | Jul 27, 2000 | Substantially Equivalent |
| K990900 | MICROKERATOME, MODEL MK-2000 | Sep 24, 1999 | Substantially Equivalent |