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FDA 510(k)

PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS

K-Number: K082243 · 2008-11-07

ApplicantGeneral Medical Merate S.P.A
Decision Date2008-11-07
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS 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 2008-11-07 under 510(k) number K082243. 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 AND DIGITAL X-RAY SYSTEMS?

PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is General Medical Merate S.P.A. The 510(k) number is K082243.

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

PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS received FDA 510(k) clearance on 2008-11-07, under 510(k) number K082243.

Who is the listed applicant for PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS?

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 AND DIGITAL X-RAY SYSTEMS?

The FDA product code for PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS is OWB.

Related Clinical Trials

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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 RF180K041605PRECISION RXI ANALOG X-RAY SYSTEMK881386X-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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