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FDA 510(k)

PRECISION RXI ANALOG X-RAY SYSTEM

K-Number: K041605 · 2004-06-30

ApplicantGeneral Medical Merate S.P.A
Decision Date2004-06-30
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRECISION RXI ANALOG X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Merate S.P.A. It received FDA 510(k) clearance on 2004-06-30 under 510(k) number K041605. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISION RXI ANALOG X-RAY SYSTEM?

PRECISION RXI ANALOG X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-30. The listed applicant is General Medical Merate S.P.A. The 510(k) number is K041605.

When did PRECISION RXI ANALOG X-RAY SYSTEM receive FDA 510(k) clearance?

PRECISION RXI ANALOG X-RAY SYSTEM received FDA 510(k) clearance on 2004-06-30, under 510(k) number K041605.

Who is the listed applicant for PRECISION RXI ANALOG X-RAY SYSTEM?

The FDA 510(k) record lists General Medical Merate S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECISION RXI ANALOG X-RAY SYSTEM?

The FDA product code for PRECISION RXI ANALOG X-RAY SYSTEM is OWB.

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 General Medical Merate S.P.A 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.

K213081CLISIS SYSTEMS, Discovery RF180K173395MECALL CLISIS SYSTEMS, Discovery RF180K082243PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMSK881386X-RAY GENERATING SYSTEM TF 1000K827993MTH C/A MOBILE C ARM

Related Devices (Code: OWB)

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.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

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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