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FDA 510(k)

ZIEHM VISION 2

K-Number: K073346 · 2008-03-21

ApplicantZiehm Imaging, Inc.
Decision Date2008-03-21
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZIEHM VISION 2 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 2008-03-21 under 510(k) number K073346. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIEHM VISION 2?

ZIEHM VISION 2 is a medical device that received FDA 510(k) clearance on 2008-03-21. The listed applicant is Ziehm Imaging, Inc.. The 510(k) number is K073346.

When did ZIEHM VISION 2 receive FDA 510(k) clearance?

ZIEHM VISION 2 received FDA 510(k) clearance on 2008-03-21, under 510(k) number K073346.

Who is the listed applicant for ZIEHM VISION 2?

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 2?

The FDA product code for ZIEHM VISION 2 is JAK.

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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 RFDK061534ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEMK061310ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEMK061203ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEMK051064ZIEHM QUANTUM

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Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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