510(k) K240369
K240369 is an FDA 510(k) premarket notification submitted by BunkerHill Health for the device "CAC (gated) Algorithm". The FDA issued a decision of Substantially Equivalent on September 27, 2024. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. BunkerHill Health has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2024
- Date Received
- February 7, 2024
- 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