B-350 CEILING MOUNTED C-POSITIONER

K970947 · Omega Medical Imaging, Inc. · JAA · May 14, 1997 · Radiology

Device Facts

• Record ID: K970947
• Device Name: B-350 CEILING MOUNTED C-POSITIONER
• Applicant: Omega Medical Imaging, Inc.
• Product Code: JAA · Radiology
• Decision Date: May 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

To support the Diagnostic Source Assembly & the Image Receptor used in performing general purpose diagnostic fluoroscopic procedures.

Device Story

B-350 Isocentric Ceiling Mounted C-Positioner; holds X-ray tube and image intensifier 180° apart in C-configuration. Ceiling-mounted rail system; motorized movement allows 30° LAO to 120° LPO positioning. Maintains isocenter throughout movement. Includes detent for A/P and lateral plane alignment. Microswitch-controlled interlock prevents X-ray exposure outside detent position. Used in clinical settings for diagnostic fluoroscopy; operated by medical staff. Supports diagnostic imaging workflow by enabling precise, stable positioning of imaging components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ceiling-mounted C-arm; motorized positioning; isocentric movement; microswitch-controlled interlock system for X-ray exposure safety. Mechanical design supports X-ray tube and image intensifier.

Indications for Use

Indicated for patients requiring general purpose diagnostic fluoroscopic procedures; device supports X-ray tube and image intensifier positioning.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Fisher’s PEGASUS Ceiling Mounted Cardiac Positioner
• Philips DIAGNOST Lateral C-Arm
• Fisher’s ARIEL Ceiling Mounted C-Arm
• Fisher’s CPS Ceiling Mounted Imaging System

Submission Summary (Full Text)

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OMEGA MEDICAL IMAGING, Inc. B-350

MAY 14 1997 K970947

# 510(k) Summary

March 25, 1997

**Submitter**: Omega Medical Imaging, Inc. 675 Hickman Circle, Sanford, FL 32771. Douglas Coon, President.

**Device Name**: B-350 Isocentric Ceiling Mounted C-Positioner.

**Classification Name**: System, Fluoroscopic, Image Intensified, All Types.

**Common/Usual Name**: C-Arm

**Substantially Equivalent Devices**: Fisher’s PEGASUS Ceiling Mounted Cardiac Positioner, Philips DIAGNOST Lateral C-Arm, Fisher’s ARIEL Ceiling Mounted C-Arm, and Fisher’s CPS Ceiling Mounted Imaging System.

**Description**: The B-350 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a “C” configuration for the purpose of performing general purpose diagnostic fluoroscopic procedures.

The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from 30 degrees Left Anterior Oblique (LAO) to 120 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails with a detent provided to lock the unit into place for use in creating a common isocenter between the Anterior/Posterior (A/P) and lateral planes. A microswitch controlled interlock system independently prevents X-Ray exposure anywhere outside the detent position.

**Intended Use**: To support the Diagnostic Source Assembly & the Image Receptor used in performing general purpose diagnostic fluoroscopic procedures.

**Summary of Technological Characteristics**: The B-350 Ceiling Mounted C-Positioner has the same technological characteristics as the predicate devices. The B-350 and the predicate devices all have the same intended use: to support the X-Ray tube (Diagnostic Source Assembly) and the Image Intensifier (Image Receptor) directly opposite each other with some variation in the distance from the X-Ray tube to the Image Receptor (SID), for diagnostic fluoroscopic procedures. The only differences in the devices are market driven variables such as the SID, arc rotation for different procedures, and the ability to rotate about the ceiling axis. The above devices are essentially all ceiling suspended C-Arms with some variations depending on user preference. The Omega B-350 Ceiling Mounted C-Positioner (C-Arm) is substantially equivalent to the predicate devices as well as any number of other Ceiling Mounted C-Arms that have been legally marketed in the U.S. for many years.