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)

G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS

K-Number: K902984 · 1990-10-26

ApplicantElectromek Diagnostic Systems, Inc.
Decision Date1990-10-26
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS is the device name listed in this FDA 510(k) record. The listed applicant is Electromek Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-10-26 under 510(k) number K902984. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS?

G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS is a medical device that received FDA 510(k) clearance on 1990-10-26. The listed applicant is Electromek Diagnostic Systems, Inc.. The 510(k) number is K902984.

When did G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS receive FDA 510(k) clearance?

G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS received FDA 510(k) clearance on 1990-10-26, under 510(k) number K902984.

Who is the listed applicant for G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS?

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

What is the FDA product code for G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS?

The FDA product code for G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS is IZL.

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 Electromek Diagnostic Systems, Inc. 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.

K902986G.E. DXD 325/350/350II/DXD 525/525II GENERATORSK902987G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORSK902988G.E. MSI 850/850II/1250 THREE PHASE GENERATORSK902985G.E. MST 625/625II/MST 1050/1050II THREE PHASE GENK902982G.E. POLARIX II C-ARMK902981G.E. FLUOROCON 300 IMAGING SYSTEM

View all 11 devices →

Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., 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.

↑