510(k) K093520
K093520 is an FDA 510(k) premarket notification submitted by Michelson Diagnostics, Ltd. for the device "VIVOSIGHT TOPICAL OCT SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 5, 2010. The device falls under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)), a Class II device regulated under 21 CFR 892.1560. Michelson Diagnostics, Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 5, 2010
- Date Received
- Nov 13, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Optical Coherence Tomography (Oct)
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- SU
- Submission Type
- 510(k)
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.