P1806 Mobile C-Arm Image Intensifier

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

510(k) Number

K792225 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Precision Optics Image Coupler

  Class II

  FDA 510(k) K903458 Active Cleared 19 Oct 1990

• PI808 Mobile C-Arm Image Intensifier

  Class II

  FDA 510(k) K820178 Active Cleared 4 Mar 1982

• Precision Optics Corporation Laparoscope

  Class II

  FDA 510(k) K911744 Active Cleared 26 Jul 1991

• P2020-8-0 Beam Limiting Device

  Class II

  FDA 510(k) K914184 Active Cleared 27 Nov 1991

• PHF20 20 Mobile C-Arm Image Intensifier

  Class II

  FDA 510(k) K935580 Active Cleared 16 Mar 1994

• Dentix Dental X-Ray Unit

  Class II

  FDA 510(k) K792307 Active Cleared 9 Jan 1980

See all devices from Precise Optics →

• What is the primary use of the P1806 Mobile C-Arm Image Intensifier?

  This device is a fluoroscopic, image-intensified X-ray system engineered to provide real-time imaging capabilities. It is intended for use during diagnostic and interventional medical procedures within a clinical radiology environment.

• What is the regulatory classification of this device?

  The P1806 is classified as a Class II medical device under regulation number 892.1650. It has received FDA 510(k) clearance under the submission number K792225.

• How was this device authorized for use?

  The device was authorized through the FDA 510(k) process, which is a traditional regulatory route. The decision was based on a finding of substantial equivalence to existing devices, as documented under the K792225 filing.