510(k) K231041
K231041 is an FDA 510(k) premarket notification submitted by Visus Health IT GmbH for the device "JiveX (Model Number / Release: 5.4)". The FDA issued a decision of Substantially Equivalent on July 14, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Visus Health IT GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2023
- Date Received
- April 12, 2023
- 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