Ceiling Mounted Fluoroscopic C-Arm Ariel C-Arm

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

510(k) Number

K880527 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Radiographic Floor Mounted Tubestand Fm 60

  Class I

  FDA 510(k) K893652 Active Cleared 23 Jun 1989

• Rms 180

  Class II

  FDA 510(k) K893673 Active Cleared 20 Jul 1989

• Elite R 90/15

  Class II

  FDA 510(k) K912741 Active Cleared 4 Oct 1991

• Fvp-1000 Family and Fvp-1000D Family

  Class II

  FDA 510(k) K905694 Active Cleared 27 Nov 1991

• Mammopath

  Class II

  FDA 510(k) K021113 Active Cleared 13 Jun 2002

• Imager

  Class II

  FDA 510(k) K883831 Active Cleared 21 Nov 1988

See all devices from Fischer Imaging Corp. →

• What types of procedures is the Ariel C-Arm ceiling-mounted fluoroscopic system designed to support in a clinical setting?

  The Ariel C-Arm is specifically designed for radiographic procedures requiring real-time visualization of internal structures, making it suitable for interventional and diagnostic radiology. This includes procedures like orthopedic surgeries, vascular interventions, and other fluoroscopy-guided treatments where precise imaging is critical.

• How is the Ariel C-Arm system supplied, and what are the requirements for reuse between patients?

  The Ariel C-Arm is supplied as a reusable system, meaning it is intended for multiple uses in a clinical environment. Between uses, it must undergo appropriate sterilization protocols to ensure patient safety and device integrity, as outlined in the manufacturer’s instructions.

• What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use in the U.S.?

  The Ariel C-Arm received FDA 510(k) clearance under K-number K880527, classified as substantially equivalent to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously cleared device, allowing it to be legally marketed in the U.S. under the regulatory category 892.1650 for fluoroscopic imaging systems.

• Are there any specific safety considerations for using this device in environments with MRI equipment?

  The available data does not provide explicit MRI safety information for the Ariel C-Arm. If used in proximity to MRI systems, clinicians should follow strict protocols to avoid interference or safety hazards, as the device’s compatibility with MRI environments is not addressed in the provided documentation.