510(k) K171977
K171977 is an FDA 510(k) premarket notification submitted by Hinacom Software And Technology, Ltd. for the device "miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer". The FDA issued a decision of Substantially Equivalent on Aug 2, 2018. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Hinacom Software And Technology, Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 2, 2018
- Date Received
- Jun 30, 2017
- 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)