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FDA 510(k)

I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)

K-Number: K111344 · 2011-06-10

ApplicantInfimed, Inc.
Decision Date2011-06-10
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) is the device name listed in this FDA 510(k) record. The listed applicant is Infimed, Inc.. It received FDA 510(k) clearance on 2011-06-10 under 510(k) number K111344. 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 I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)?

I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) is a medical device that received FDA 510(k) clearance on 2011-06-10. The listed applicant is Infimed, Inc.. The 510(k) number is K111344.

When did I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) receive FDA 510(k) clearance?

I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) received FDA 510(k) clearance on 2011-06-10, under 510(k) number K111344.

Who is the listed applicant for I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)?

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

What is the FDA product code for I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)?

The FDA product code for I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) is OWB.

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Other records listing Infimed, 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.

K112180I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)K103416NEXUS DRF DIGITAL X-RAY IMAGING SYSTEMK101833INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5K093066I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5K012490ORION DIGITAL IMAGING SYSTEMK992392RTLX

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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

View on FDA Database →

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

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