Devices · Verathon Incorporated
BladderScan Prime PLUS System
510(k)K172356RadiologyIYO
Verathon Incorporated is listed for BladderScan Prime PLUS System (K172356). The FDA list gives September 15, 2017 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is IYO. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172356
- Date of final decision
- September 15, 2017
- Company on the FDA list
- Verathon Incorporated
- Lead panel
- Radiology
- Primary product code
- IYO
- openFDA device name for the code
- System, Imaging, Pulsed Echo, Ultrasonic
- Device class
- 2
- Regulation number
- 892.1560
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary