510(k) K181343
K181343 is an FDA 510(k) premarket notification submitted by Bracco Diagnostics, Inc. for the device "HeartSee Cardiac P.E.T. Processing Software". The FDA issued a decision of Substantially Equivalent on June 12, 2018. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Bracco Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2018
- Date Received
- May 21, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type