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)

ADVANTX 1824 SPOTFILM DEVICE

K-Number: K950317 · 1995-02-08

ApplicantGE Medical Systems
Decision Date1995-02-08
Product CodeIXL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADVANTX 1824 SPOTFILM DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1995-02-08 under 510(k) number K950317. The device is classified under product code IXL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANTX 1824 SPOTFILM DEVICE?

ADVANTX 1824 SPOTFILM DEVICE is a medical device that received FDA 510(k) clearance on 1995-02-08. The listed applicant is GE Medical Systems. The 510(k) number is K950317.

When did ADVANTX 1824 SPOTFILM DEVICE receive FDA 510(k) clearance?

ADVANTX 1824 SPOTFILM DEVICE received FDA 510(k) clearance on 1995-02-08, under 510(k) number K950317.

Who is the listed applicant for ADVANTX 1824 SPOTFILM DEVICE?

The FDA 510(k) record lists GE Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANTX 1824 SPOTFILM DEVICE?

The FDA product code for ADVANTX 1824 SPOTFILM DEVICE is IXL.

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 GE Medical Systems 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.

K253808AIR Recon DLK220848Venue FitK220851VenueK173341Vivid E80, Vivid E90, Vivid E95K103411IDEAL IQ SOFTWARE OPTIONK073138CARDIQ EXPRESS VERSION 2.0

View all 170 devices →

Related Devices (Code: IXL)

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.

K111304OPTIMA XR120Ge Medical Systems, LLCK964806MD-1835Fischer Imaging Corp.K940386KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LPEastman Kodak CompanyK942367AXT 1400 SPOTFILM DEVICEApplied X-Ray Technologies, Inc.K924593DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4Philips Medical Systems, Inc.K902403ELITE R/F SPOT FILM DRIVERms Div.

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.

↑