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FDA 510(k)

ZIEHM SOLO

K-Number: K092438 · 2009-12-23

ApplicantZiehm Imaging, Inc.
Decision Date2009-12-23
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZIEHM SOLO 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 2009-12-23 under 510(k) number K092438. 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 SOLO?

ZIEHM SOLO is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Ziehm Imaging, Inc.. The 510(k) number is K092438.

When did ZIEHM SOLO receive FDA 510(k) clearance?

ZIEHM SOLO received FDA 510(k) clearance on 2009-12-23, under 510(k) number K092438.

Who is the listed applicant for ZIEHM SOLO?

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 SOLO?

The FDA product code for ZIEHM SOLO 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.

K083545ZIEHM VISION RFDK073346ZIEHM VISION 2K061534ZIEHM 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: 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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