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)

GE ADVANTAGE DIGITIZER WORKSTATION

K-Number: K970628 · 1997-05-12

ApplicantGe Medical Systems, Inc.
Decision Date1997-05-12
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE ADVANTAGE DIGITIZER WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-05-12 under 510(k) number K970628. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE ADVANTAGE DIGITIZER WORKSTATION?

GE ADVANTAGE DIGITIZER WORKSTATION is a medical device that received FDA 510(k) clearance on 1997-05-12. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K970628.

When did GE ADVANTAGE DIGITIZER WORKSTATION receive FDA 510(k) clearance?

GE ADVANTAGE DIGITIZER WORKSTATION received FDA 510(k) clearance on 1997-05-12, under 510(k) number K970628.

Who is the listed applicant for GE ADVANTAGE DIGITIZER WORKSTATION?

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

What is the FDA product code for GE ADVANTAGE DIGITIZER WORKSTATION?

The FDA product code for GE ADVANTAGE DIGITIZER WORKSTATION is LMD.

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, 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.

K091673GE LIGHTSPEED ACT FP16K082104GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEMK042844GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COILK042053INNOVA 4100, INNOVA 3100K040125SENOGRAPHIC STEREOK033244DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION

View all 54 devices →

Related Devices (Code: LMD)

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.

K994329IIVS INTEGRATED IMAGE VIEWING STATIONTerarecon,Inc.K992698STENTOR, PAGEVIEWStentor, Inc.K992426RAYPAX WEB CLINICAL SYSTEMSamsung Sds Co., Ltd.K992352ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0Inteleradiology, Inc.K991537SAMSUNG RAYPAX SYSTEMSamsung Sds Co., Ltd.K984000STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEMSurgical Navigation Technologies, 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.

↑