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)

DATASON DB ULTRASOUND IMAGING SYSTEM

K-Number: K810305 · 1981-03-13

ApplicantGeneral Electric Co.
Decision Date1981-03-13
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DATASON DB ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1981-03-13 under 510(k) number K810305. The device is classified under product code HEM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATASON DB ULTRASOUND IMAGING SYSTEM?

DATASON DB ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is General Electric Co.. The 510(k) number is K810305.

When did DATASON DB ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

DATASON DB ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1981-03-13, under 510(k) number K810305.

Who is the listed applicant for DATASON DB ULTRASOUND IMAGING SYSTEM?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DATASON DB ULTRASOUND IMAGING SYSTEM?

The FDA product code for DATASON DB ULTRASOUND IMAGING SYSTEM is HEM.

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 General Electric Co. 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.

K103489GE VEO RECONSTRUCTION OPTIONK082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTIONK081921GE VIVID E9 ULTRASOUNDK073297GE LOGIQ P6K072952GE ECHOPACK072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

View all 254 devices →

Related Devices (Code: HEM)

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.

K951393ABACUS OB ULTRASOUNG COMPUTER SOFTWARESolomon Technology LabsK942490BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUNDMedical Soft, Inc.K910426SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENTShimadzu Medical SystemsK905000ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERCorometrics Medical Systems, Inc.K900505SONOACE 88 PORTABLE ULTRASOUND SCANNERMedison Co., Ltd.K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKDigisonics, 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.

↑