Philips CT 3500
K-Number: K223311 · 2022-12-22
Decision Date2022-12-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Philips CT 3500 is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-12-22 under approval number K223311. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Philips CT 3500?
Philips CT 3500 is a medical device that received FDA 510(k) clearance on 2022-12-22. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K223311.
When was Philips CT 3500 approved by the FDA?
Philips CT 3500 received FDA 510(k) clearance on 2022-12-22, under approval number K223311.
What company makes Philips CT 3500?
Philips CT 3500 is manufactured by Philips Healthcare (Suzhou) Co., Ltd..
What is the FDA product code for Philips CT 3500?
The FDA product code for Philips CT 3500 is JAK.
Other Devices by Philips Healthcare (Suzhou) Co., Ltd.
Related Devices (Code: JAK)
K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.
K163213Revolution CTGe Medical Systems, LLC
K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.
K160723OnSight 3D Extremity SystemCarestream Health, Inc.
K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.
K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.