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

FDA 510(k)

ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.

K-Number: K874861 · 1988-05-11

ApplicantAcuson Computed Sonography
Decision Date1988-05-11
Product CodeDPT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Computed Sonography. It received FDA 510(k) clearance on 1988-05-11 under 510(k) number K874861. The device is classified under product code DPT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.?

ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. is a medical device that received FDA 510(k) clearance on 1988-05-11. The listed applicant is Acuson Computed Sonography. The 510(k) number is K874861.

When did ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. receive FDA 510(k) clearance?

ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. received FDA 510(k) clearance on 1988-05-11, under 510(k) number K874861.

Who is the listed applicant for ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.?

The FDA 510(k) record lists Acuson Computed Sonography as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.?

The FDA product code for ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. is DPT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Acuson Computed Sonography as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K893863ACUSON L538 TRANSDUCERK874028ACUSON S328 TRANSDUCERK874363ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.K874922ACUSON TRANSPERINEAL NEEDLE GUIDEK874860ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.K871506ACUSON L538 TRANSDUCER

View all 24 devices →

Related Devices (Code: DPT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233076Laser Speckle Imaging System (RFLSI CZW)Rwd Life Science Co., Ltd.K163339SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0Spectralmd, Inc.K152749moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imagerMoor Instruments, Ltd.K124049DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEMSpectralmd, Inc.K123216AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE ANAimago SAK122943MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGERMoor Instruments, Ltd.

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.

↑