FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
VivoSight Dx Topical OCT System
K Number: K153283
·
Decision Aug 11, 2016
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
45
Applicant Total
2
Review Days
273
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Basic Information
- Device Name
- VivoSight Dx Topical OCT System
- K Number
- K153283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Michelson Diagnostics, Ltd.
- Date Received
- November 12, 2015
- Decision Date
- August 11, 2016
- Product Code
- NQQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | FDA class 2 | Radiology |
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Other Clearances by Michelson Diagnostics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K093520 | VIVOSIGHT TOPICAL OCT SYSTEM | Jan 5, 2010 | Substantially Equivalent |