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)

QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE

K-Number: K894854 · 1989-10-19

ApplicantImage Enhancements
Decision Date1989-10-19
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Image Enhancements. It received FDA 510(k) clearance on 1989-10-19 under 510(k) number K894854. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE?

QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE is a medical device that received FDA 510(k) clearance on 1989-10-19. The listed applicant is Image Enhancements. The 510(k) number is K894854.

When did QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE receive FDA 510(k) clearance?

QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE received FDA 510(k) clearance on 1989-10-19, under 510(k) number K894854.

Who is the listed applicant for QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE?

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

What is the FDA product code for QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE?

The FDA product code for QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE is KGI.

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

Related Devices (Code: KGI)

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.

K254072BoneVueCurvebeam AI / Curvebeam, LLCK252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK2510223D-SHAPER3D-Shaper Medical S.LK242295BunkerHill BMDBunkerHill HealthK243218TBS iNsight (V4)Medimaps Group SAK220402VirtuOstO.N. Diagnostics

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.

↑