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)

DTX-200 BONE DENSITOMETER

K-Number: K961011 · 1996-07-05

ApplicantShotwell & Carr, Inc.
Decision Date1996-07-05
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DTX-200 BONE DENSITOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Shotwell & Carr, Inc.. It received FDA 510(k) clearance on 1996-07-05 under 510(k) number K961011. 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 DTX-200 BONE DENSITOMETER?

DTX-200 BONE DENSITOMETER is a medical device that received FDA 510(k) clearance on 1996-07-05. The listed applicant is Shotwell & Carr, Inc.. The 510(k) number is K961011.

When did DTX-200 BONE DENSITOMETER receive FDA 510(k) clearance?

DTX-200 BONE DENSITOMETER received FDA 510(k) clearance on 1996-07-05, under 510(k) number K961011.

Who is the listed applicant for DTX-200 BONE DENSITOMETER?

The FDA 510(k) record lists Shotwell & Carr, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DTX-200 BONE DENSITOMETER?

The FDA product code for DTX-200 BONE DENSITOMETER 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 Shotwell & Carr, 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.

K970824MDX 2000, DIGITAL ANALYZERK950617SMART WAVE GS100

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.

↑