510(k) K173088
K173088 is an FDA 510(k) premarket notification submitted by Toshibamedical Systems Corporation for the device "Vitrea Software Toshiba Package VSTP-001A". The FDA issued a decision of Substantially Equivalent on Jan 31, 2018. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Toshibamedical Systems Corporation has 79 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 31, 2018
- Date Received
- Sep 29, 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)