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FDA 510(k)

PRONOSCO X-POSURE SYSTEM

K-Number: K984178 · 1999-02-18

ApplicantTorsana Osteoporosis Diagnostics A/S
Decision Date1999-02-18
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRONOSCO X-POSURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Torsana Osteoporosis Diagnostics A/S. It received FDA 510(k) clearance on 1999-02-18 under 510(k) number K984178. 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 PRONOSCO X-POSURE SYSTEM?

PRONOSCO X-POSURE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-18. The listed applicant is Torsana Osteoporosis Diagnostics A/S. The 510(k) number is K984178.

When did PRONOSCO X-POSURE SYSTEM receive FDA 510(k) clearance?

PRONOSCO X-POSURE SYSTEM received FDA 510(k) clearance on 1999-02-18, under 510(k) number K984178.

Who is the listed applicant for PRONOSCO X-POSURE SYSTEM?

The FDA 510(k) record lists Torsana Osteoporosis Diagnostics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRONOSCO X-POSURE SYSTEM?

The FDA product code for PRONOSCO X-POSURE SYSTEM is KGI.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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