FDA 510(k)

Ziehm Solo FD

K-Number: K243646 · 2025-03-17

Decision Date2025-03-17

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Ziehm Solo FD is a medical device manufactured by Ziehm Imaging GmbH. It received FDA 510(k) clearance on 2025-03-17 under approval number K243646. 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 FD?

Ziehm Solo FD is a medical device that received FDA 510(k) clearance on 2025-03-17. It is manufactured by Ziehm Imaging GmbH. The 510(k) number is K243646.

When was Ziehm Solo FD approved by the FDA?

Ziehm Solo FD received FDA 510(k) clearance on 2025-03-17, under approval number K243646.

What company makes Ziehm Solo FD?

Ziehm Solo FD is manufactured by Ziehm Imaging GmbH.

What is the FDA product code for Ziehm Solo FD?

The FDA product code for Ziehm Solo FD is OWB.

Other Devices by Ziehm Imaging GmbH

K161976Ziehm Solo FD K193230Ziehm Vision FD K190497Ziehm 8000 K202360Ziehm Vision RFD 3D K203428Ziehm Vision RFD K231700Ziehm Vision FD

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Related Devices (Code: OWB)

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. K162148Allura Xper R9Philips Medical Systems Nethrlands BV K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. K161976Ziehm Solo FDZiehm Imaging GmbH K161756SyncVision SystemVolcano Corporation

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.