Devices · Philips Healthcare (Suzhou) Co., Ltd

Philips CT 3500

510(k)K223311RadiologyJAK

Philips Healthcare (Suzhou) Co., Ltd is listed for Philips CT 3500 (K223311). The FDA list gives December 22, 2022 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 JAK. 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=K223311

Official FDA database record

Date of final decision: December 22, 2022
Company on the FDA list: Philips Healthcare (Suzhou) Co., Ltd
Lead panel: Radiology
Primary product code: JAK
openFDA device name for the code: System, X-Ray, Tomography, Computed
Device class: 2
Regulation number: 892.1750
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary