FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
3D OCT-1 Maestro
K Number: K170164
·
Decision Mar 3, 2017
Classifications
1
FEI Numbers
29
Registration Numbers
30
Same Product Code
65
Applicant Total
13
Review Days
44
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Basic Information
- Device Name
- 3D OCT-1 Maestro
- K Number
- K170164
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Topcon Corporation
- Date Received
- January 18, 2017
- Decision Date
- March 3, 2017
- Product Code
- OBO
- 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 |
|---|---|---|---|
| OBO | Tomography, Optical Coherence | FDA class 2 | Ophthalmic |
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Anterion
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SPECTRALIS with Flex Module
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| K173119 | DRI OCT Triton | Jan 19, 2018 | Substantially Equivalent |
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| K161972 | Slit Lamp SL-D301 | Dec 9, 2016 | Substantially Equivalent |
| K161509 | 3D OCT-1 Maestro | Jul 28, 2016 | Substantially Equivalent |