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)

NanoZoomer S360MD Slide scanner system

K-Number: K233027 · 2023-12-22

ApplicantHamamatsu Photonics K.K.
Decision Date2023-12-22
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

NanoZoomer S360MD Slide scanner system is a medical device manufactured by Hamamatsu Photonics K.K.. It received FDA 510(k) clearance on 2023-12-22 under approval number K233027. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NanoZoomer S360MD Slide scanner system?

NanoZoomer S360MD Slide scanner system is a medical device that received FDA 510(k) clearance on 2023-12-22. It is manufactured by Hamamatsu Photonics K.K.. The 510(k) number is K233027.

When was NanoZoomer S360MD Slide scanner system approved by the FDA?

NanoZoomer S360MD Slide scanner system received FDA 510(k) clearance on 2023-12-22, under approval number K233027.

What company makes NanoZoomer S360MD Slide scanner system?

NanoZoomer S360MD Slide scanner system is manufactured by Hamamatsu Photonics K.K..

What is the FDA product code for NanoZoomer S360MD Slide scanner system?

The FDA product code for NanoZoomer S360MD Slide scanner system is PSY.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT02108054 Behavioral and Functional Task Development, Implementation, and Testing RECRUITING NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT06472622 Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort RECRUITING NCT04798274 Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder RECRUITING

Other Devices by Hamamatsu Photonics K.K.

K162117NIRO-200NX DP K213883NanoZoomer S360MD Slide scanner system

Related Devices (Code: PSY)

K172174Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. DEN160056Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. K192259Philips IntelliSite Pathology SolutionPhilips Electronics Nederland B.V. K190332Aperio AT2 DX SystemLeica Biosystems Imaging, Inc. K203845Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. K203364MDPC-8127Barco N.V.

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.

↑