FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
K Number: K971685
·
Decision Jun 24, 1997
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
9
Review Days
48
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Basic Information
- Device Name
- IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
- K Number
- K971685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tomey Corporation USA
- Date Received
- May 7, 1997
- Decision Date
- June 24, 1997
- 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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|---|---|---|---|
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| K944910 | TOMEY EM-1000 SPECULAR MICROSCOPE | Nov 22, 1994 | Substantially Equivalent |
| K924760 | TOMEY PROTON TONOMETER | Apr 5, 1993 | Substantially Equivalent |
| K921815 | TOMEY PE-300 PORTABLE ERG | Jul 15, 1992 | Substantially Equivalent |
| K912112 | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 | Jun 17, 1991 | Substantially Equivalent |