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FDA 510(k)

Ziehm Vision RFD 3D

K-Number: K243303 · 2025-01-21

ApplicantZiehm Imaging GmbH
Decision Date2025-01-21
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ziehm Vision RFD 3D is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm Imaging GmbH. It received FDA 510(k) clearance on 2025-01-21 under 510(k) number K243303. 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 RFD 3D?

Ziehm Vision RFD 3D is a medical device that received FDA 510(k) clearance on 2025-01-21. The listed applicant is Ziehm Imaging GmbH. The 510(k) number is K243303.

When did Ziehm Vision RFD 3D receive FDA 510(k) clearance?

Ziehm Vision RFD 3D received FDA 510(k) clearance on 2025-01-21, under 510(k) number K243303.

Who is the listed applicant for Ziehm Vision RFD 3D?

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

What is the FDA product code for Ziehm Vision RFD 3D?

The FDA product code for Ziehm Vision RFD 3D is OWB.

Other records listing Ziehm Imaging GmbH 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.

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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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