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FDA 510(k)

TOPA12 Portable X-ray Unit

K-Number: K230581 · 2023-08-16

ApplicantNeuf, Inc.
Decision Date2023-08-16
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOPA12 Portable X-ray Unit is a medical device manufactured by Neuf, Inc.. It received FDA 510(k) clearance on 2023-08-16 under approval number K230581. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOPA12 Portable X-ray Unit?

TOPA12 Portable X-ray Unit is a medical device that received FDA 510(k) clearance on 2023-08-16. It is manufactured by Neuf, Inc.. The 510(k) number is K230581.

When was TOPA12 Portable X-ray Unit approved by the FDA?

TOPA12 Portable X-ray Unit received FDA 510(k) clearance on 2023-08-16, under approval number K230581.

What company makes TOPA12 Portable X-ray Unit?

TOPA12 Portable X-ray Unit is manufactured by Neuf, Inc..

What is the FDA product code for TOPA12 Portable X-ray Unit?

The FDA product code for TOPA12 Portable X-ray Unit is IZL.

Other Devices by Neuf, Inc.

K211383NFLK-2501 Portable X-ray Unit

Related Devices (Code: IZL)

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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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