Hydra View Imaging System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K901323 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Mallinckrodt Group, Inc. →

• What is the Hydra View Imaging System used for?

  The Hydra View Imaging System is used in radiology for fluoroscopy.

• Is the Hydra View Imaging System supplied sterile?

  The description does not specify if the system is supplied sterile, but it is classified as a Class II system.

• What is the regulatory classification of the Hydra View Imaging System?

  The Hydra View Imaging System is regulated under 892.1650 and has been cleared under the FDA 510(k) number K901323.