510(k) K242119
K242119 is an FDA 510(k) premarket notification submitted by Dk Medical System for the device "INNOVISION-EXII". The FDA issued a decision of Substantially Equivalent on January 3, 2025. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2025
- Date Received
- July 19, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type