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FDA 510(k)

I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)

K-Number: K112180 · 2011-08-10

ApplicantInfimed, Inc.
Decision Date2011-08-10
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) is the device name listed in this FDA 510(k) record. The listed applicant is Infimed, Inc.. It received FDA 510(k) clearance on 2011-08-10 under 510(k) number K112180. 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 SDX-4336CP)?

I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) is a medical device that received FDA 510(k) clearance on 2011-08-10. The listed applicant is Infimed, Inc.. The 510(k) number is K112180.

When did I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) receive FDA 510(k) clearance?

I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) received FDA 510(k) clearance on 2011-08-10, under 510(k) number K112180.

Who is the listed applicant for I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)?

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 SDX-4336CP)?

The FDA product code for I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) 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.

K111344I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)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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