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)

ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT

K-Number: K914404 · 1992-02-27

ApplicantLunar
Decision Date1992-02-27
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT is the device name listed in this FDA 510(k) record. The listed applicant is Lunar. It received FDA 510(k) clearance on 1992-02-27 under 510(k) number K914404. 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 ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT?

ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT is a medical device that received FDA 510(k) clearance on 1992-02-27. The listed applicant is Lunar. The 510(k) number is K914404.

When did ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT receive FDA 510(k) clearance?

ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT received FDA 510(k) clearance on 1992-02-27, under 510(k) number K914404.

Who is the listed applicant for ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT?

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

What is the FDA product code for ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT?

The FDA product code for ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT 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

Other records listing Lunar 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.

K915535FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOMK905291LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHAK904980DPX-L AND DPX-ALPHA, MODIFICATIONK890121MODIFIED DPX BONE DENSITOMETERK884625DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY

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.

↑