Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Brain Perfusion (BP) application

K-Number: K182716 · 2019-05-29

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2019-05-29
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Brain Perfusion (BP) application is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2019-05-29 under approval number K182716. 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 Brain Perfusion (BP) application?

Brain Perfusion (BP) application is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K182716.

When was Brain Perfusion (BP) application approved by the FDA?

Brain Perfusion (BP) application received FDA 510(k) clearance on 2019-05-29, under approval number K182716.

What company makes Brain Perfusion (BP) application?

Brain Perfusion (BP) application is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Brain Perfusion (BP) application?

The FDA product code for Brain Perfusion (BP) application is JAK.

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT04325230 Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy COMPLETED NCT07584382 The Effect of Static Magnetic Fields on Neuroinflammation in Migraine NOT_YET_RECRUITING NCT06395649 Personalized Treatment by rTMS in Chronic Pain RECRUITING NCT07554599 Nonoinvasive HPI in Beach-chair Position NOT_YET_RECRUITING NCT07573566 Abdominal Aortic Tourniquet Application for Non-Traumatic Out-of-Hospital Cardiac Arrest NOT_YET_RECRUITING

Other Devices by Philips Medical Systems Nederland B.V.

K162940MultiBand SENSE K162955Multi-Modality Tumor Tracking (MMTT) application K162859Allura Xper FD series and Allura Xper OR Table series K160455AneurysmFlow K160147CT TrueView K1618392D Quantitative Analysis

View all 77 devices →

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.

↑