510(k) K232412
K232412 is an FDA 510(k) premarket notification submitted by Thirona BV for the device "LungQ v3.0.0". The FDA issued a decision of Substantially Equivalent on January 8, 2024. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Thirona BV has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 2024
- Date Received
- August 10, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type