510(k) K143176
K143176 is an FDA 510(k) premarket notification submitted by Ultralinq Healthcare Solutions, Inc. for the device "UltraLinq". The FDA issued a decision of Substantially Equivalent on Jul 17, 2015. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 17, 2015
- Date Received
- Nov 4, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)