510(k) K150618
K150618 is an FDA 510(k) premarket notification submitted by Pentax of America, Inc. for the device "PENTAX Medical EPK-i7010 Video Processor with GI Family". The FDA issued a decision of Substantially Equivalent on November 24, 2015. The device falls under product code PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement), a Class II device regulated under 21 CFR 876.1500. Pentax of America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2015
- Date Received
- March 10, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Accessories, Image Post-Processing For Color Enhancement
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.