Top-X 650HF Radiographic X-Ray

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

510(k) Number

K920347 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• B-4 Four-Way Radiographic Table

  Class II

  FDA 510(k) K924444 Active Cleared 5 Feb 1993

• Ba-4 Wall Bucky and Ba-42 Tilting Wall Bucky

  Class I

  FDA 510(k) K924445 Active Cleared 19 Feb 1993

• Milestone Ms 325 Radiographic X-Ray Generator

  Class I

  FDA 510(k) K913577 Active Cleared 5 Nov 1991

• Pcx 1050HF Radiographic X-Ray Generator

  Class I

  FDA 510(k) K920349 Active Cleared 12 Feb 1993

• Pcx 650HF Radiographic X-Ray

  Class I

  FDA 510(k) K920351 Active Cleared 12 Feb 1993

• Rs-3 Universal Radiographic Working Place

  Class II

  FDA 510(k) K924443 Active Cleared 5 Feb 1993

See all devices from Control-X, Inc. →

• What is the TOP-X 650HF Radiographic X-Ray System used for?

  The TOP-X 650HF is a stationary x-ray system designed to generate and control x-rays for examination of various anatomical regions. It includes signal analysis and display equipment, patient and equipment supports, component parts, and accessories for use in radiology departments.

• How is the TOP-X 650HF supplied and what is its regulatory status?

  The device is supplied as a stationary system and is classified as a Class II X-ray system. It received FDA 510(k) clearance with K-number K920347 in 1993, making it substantially equivalent to other legally marketed devices.

• What components are included with the TOP-X 650HF Radiographic X-Ray System?

  The system includes the main x-ray generator and control unit, along with signal analysis and display equipment. It also comes with patient positioning supports, equipment supports, and various component parts and accessories necessary for radiographic examinations.

• Is the TOP-X 650HF suitable for all anatomical regions?

  Yes, the TOP-X 650HF is intended for examination of various anatomical regions. Its stationary design and comprehensive supporting equipment make it versatile for different radiographic imaging needs in clinical settings.