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)

STARPORT MODEL H3300AA

K-Number: K852648 · 1986-01-30

ApplicantGeneral Electric Co.
Decision Date1986-01-30
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STARPORT MODEL H3300AA 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 1986-01-30 under 510(k) number K852648. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARPORT MODEL H3300AA?

STARPORT MODEL H3300AA is a medical device that received FDA 510(k) clearance on 1986-01-30. The listed applicant is General Electric Co.. The 510(k) number is K852648.

When did STARPORT MODEL H3300AA receive FDA 510(k) clearance?

STARPORT MODEL H3300AA received FDA 510(k) clearance on 1986-01-30, under 510(k) number K852648.

Who is the listed applicant for STARPORT MODEL H3300AA?

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 STARPORT MODEL H3300AA?

The FDA product code for STARPORT MODEL H3300AA is IYX.

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: IYX)

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.

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation SafetyK2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLCK163687OLINDA EXMHermes Medical Solutions ABK160933Discovery NM 750b BopsyGE HealthcareK162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-K123408ERGO IMAGING SYSTEMDigirad Corp.

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.

↑