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FDA 510(k)

X-POSURE SYSTEM VERSION 2 MAMMO

K-Number: K003656 · 2000-12-15

ApplicantPronosco A/S
Decision Date2000-12-15
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-POSURE SYSTEM VERSION 2 MAMMO is the device name listed in this FDA 510(k) record. The listed applicant is Pronosco A/S. It received FDA 510(k) clearance on 2000-12-15 under 510(k) number K003656. 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 X-POSURE SYSTEM VERSION 2 MAMMO?

X-POSURE SYSTEM VERSION 2 MAMMO is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Pronosco A/S. The 510(k) number is K003656.

When did X-POSURE SYSTEM VERSION 2 MAMMO receive FDA 510(k) clearance?

X-POSURE SYSTEM VERSION 2 MAMMO received FDA 510(k) clearance on 2000-12-15, under 510(k) number K003656.

Who is the listed applicant for X-POSURE SYSTEM VERSION 2 MAMMO?

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

What is the FDA product code for X-POSURE SYSTEM VERSION 2 MAMMO?

The FDA product code for X-POSURE SYSTEM VERSION 2 MAMMO 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.

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Other records listing Pronosco A/S 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.

K002500X-POSURE SYSTEM VERSION 2 RAD

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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