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FDA 510(k)

ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM

K-Number: K061534 · 2006-07-07

ApplicantZiehm Imaging, Inc.
Decision Date2006-07-07
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm Imaging, Inc.. It received FDA 510(k) clearance on 2006-07-07 under 510(k) number K061534. 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 ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM?

ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-07. The listed applicant is Ziehm Imaging, Inc.. The 510(k) number is K061534.

When did ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM receive FDA 510(k) clearance?

ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM received FDA 510(k) clearance on 2006-07-07, under 510(k) number K061534.

Who is the listed applicant for ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM?

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

What is the FDA product code for ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM?

The FDA product code for ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM is OWB.

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Other records listing Ziehm Imaging, 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.

K092438ZIEHM SOLOK083545ZIEHM VISION RFDK073346ZIEHM VISION 2K061310ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEMK061203ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEMK051064ZIEHM QUANTUM

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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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