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)

DIAG. ULTRASOUND B-SCANNER

K-Number: K771869 · 1977-11-02

ApplicantAccusonics, Inc.
Decision Date1977-11-02
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DIAG. ULTRASOUND B-SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Accusonics, Inc.. It received FDA 510(k) clearance on 1977-11-02 under 510(k) number K771869. The device is classified under product code HGL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAG. ULTRASOUND B-SCANNER?

DIAG. ULTRASOUND B-SCANNER is a medical device that received FDA 510(k) clearance on 1977-11-02. The listed applicant is Accusonics, Inc.. The 510(k) number is K771869.

When did DIAG. ULTRASOUND B-SCANNER receive FDA 510(k) clearance?

DIAG. ULTRASOUND B-SCANNER received FDA 510(k) clearance on 1977-11-02, under 510(k) number K771869.

Who is the listed applicant for DIAG. ULTRASOUND B-SCANNER?

The FDA 510(k) record lists Accusonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAG. ULTRASOUND B-SCANNER?

The FDA product code for DIAG. ULTRASOUND B-SCANNER is HGL.

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

Related Devices (Code: HGL)

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.

K952031ULTRASOUND TRANSDUCER, MODEL US917Advanced Medical Systems, Inc.K923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONAdvanced Medical Systems, Inc.K924516OP3/VP4Huntleigh Technology, Inc.K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEMAdvanced Technology Laboratories, Inc.K900966EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBEHitachi Medical Corp. of AmericaK901142MER MULTIPLANE VAGINAL PROBE (MVP)Medical Equipment Resources

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.

↑