510(k) K170167
K170167 is an FDA 510(k) premarket notification submitted by Echopixel, Inc. for the device "True 3D Viewer Software". The FDA issued a decision of Substantially Equivalent on March 3, 2017. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Echopixel, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 2017
- Date Received
- January 19, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type