FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
K Number: K092374
·
Decision Nov 17, 2009
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
5
Review Days
104
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Basic Information
- Device Name
- OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
- K Number
- K092374
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ophthalmic Imaging Systems
- Date Received
- August 5, 2009
- Decision Date
- November 17, 2009
- Product Code
- HKI
- Advisory Committee
- Ophthalmic
- 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 |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Ophthalmic Imaging Systems
| K Number | Device Name | ||
|---|---|---|---|
| K110006 | OIS SYMPHONY IMAGE MANAGMENT SYSTEM | May 18, 2011 | Substantially Equivalent |
| K982689 | WINSTATION RETINAL IMAGER | Oct 23, 1998 | Substantially Equivalent |
| K913929 | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM | Nov 27, 1991 | Substantially Equivalent |
| K913118 | GLAUCOMA-SCOPE | Oct 9, 1991 | Substantially Equivalent |