510(k) K123599
K123599 is an FDA 510(k) premarket notification submitted by Philips Healthcare (Cleveland) for the device "INGENUITY DIGITAL PET/CT". The FDA issued a decision of Substantially Equivalent on Jul 12, 2013. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Philips Healthcare (Cleveland) has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 12, 2013
- Date Received
- Nov 21, 2012
- 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
- 510(k)