PHILIPS EASY DIAGNOST

K970640 · Philips Medical Systems North America, Inc. · IXR · Mar 21, 1997 · Radiology

Device Facts

• Record ID: K970640
• Device Name: PHILIPS EASY DIAGNOST
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: IXR · Radiology
• Decision Date: Mar 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1980
• Device Class: Class 2

Intended Use

The intended use of the Philips EasyDIAGNOST is the same as for the Philips DIAGNOST 76 plus.

Device Story

Philips EasyDIAGNOST is a floor-mounted, tilting R/F patient support table with integrated spot film device, image intensifier, and TV camera. System components include Philips generators (Medio, Super CP, OPTIMUS), digital spot film cameras (DSI family), EASYVISION workstation, XTV imaging system, and X-ray tubes. Optional second plane configuration allows overtable tube operation with bucky tray or wallstand. Grid Controlled Fluoroscopy (GCF) uses SRM grid-switched X-ray tube to control fluoroscopic pulse shapes, reducing radiation dose and improving image quality. Operated by clinicians in diagnostic imaging environments. Output consists of fluoroscopic and radiographic images displayed on monitors for diagnostic decision-making.

Clinical Evidence

No clinical data provided. Safety and effectiveness are based on the device's use of mature technology, compliance with established national and international safety standards, and equivalence to the predicate device.

Technological Characteristics

Multi-functional R/F system; floor-mounted tilting table; trimode Image Intensifier; XTV imaging system; glass or metal X-ray tubes; SRM (metal) grid-switched tube for GCF. Compliance: CFR 1020.30, .31, .32; UL 187; IEC 601-1; IEC 601-2-7. Connectivity: Integrated with generators, digital cameras, and workstations.

Indications for Use

Indicated for routine X-ray diagnosis in clinical settings, utilizing a multi-functional R/F system for fluoroscopic and radiographic imaging.

Regulatory Classification

Identification

A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

Predicate Devices

• Philips DIAGNOST 76 plus (K924593)

Reference Devices

• DIAGNOST 73

Submission Summary (Full Text)

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MAR 21 1997
K970640

# 510(k) Summary of Safety and Effectiness

In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a Summary of Safety and Effectiveness.

CLASSIFICATION NAME: Table 21CFR 892.1980 (90 IXR)
Spot Film Device 21CFR 892.1670 (90 IXL)
Class II

COMMON/USUAL NAME: R/F System (R/F Table)

TRADE/PROPRIETARY NAME: PHILIPS EasyDIAGNOST

ESTABLISHMENT No. 1217116

PERFORMANCE STANDARDS:

This device complies with the federal X-Ray performance standards (CFR 1020.30, .31, .32) as well as with the relevant national and international standards for Electrical and Mechanical Safety (UL 187, IEC 601-1, IEC 601-2-7).

SYSTEM DESCRIPTION:

The Philips EasyDIAGNOST is a multi-functional R/F system consisting of a floor-mounted tilting patient support table and a spotfilm device holding an image intensifier and the TV camera. The tabletop can be moved by motor in longitudinal and lateral directions. The spot film device tilts with the table, and can be moved in three directions, relative to the table and to the patient. As a fully integrated system, it can be configured with generators from the Philips Medio, Super CP, and OPTIMUS families, with digital spot film cameras from the Philips DSI family, and with a Philips EASYVISION workstation. The system comes with a trimode Image Intensifier, XTV imaging system, Philips glass or metal X-ray tube(s), and TV monitor(s). An optional dedicated ultrasound system (Scanner 200X) can also be added.

The system can also be extended with an overtable tube which operates on a bucky tray inside the table and/or on a bucky wallstand (so-called second plane). This second plane option is identical to a Philips bucky DIAGNOST system, except for the table itself.

Philips Grid Controlled Fluoroscopy (GCF) can be provided using an SRM (metal) grid-switched X-ray tube. GCF improves overall image quality and provides dose reduction through precise control of fluoroscopic pulse shapes, eliminating excess radiation associated with pulse ramping and trailing effects of conventional pulsed fluoroscopy.

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# EQUIVALENCE INFORMATION:

The Philips EasyDIAGNOST is a modification of, and substantially equivalent to, the Philips DIAGNOST 76 plus manufactured by Philips Medical Systems. The DIAGNOST 76 plus received 510(k) clearance November 24, 1992 (see 510(k) K924593). The DIAGNOST 76 plus was found substantially equivalent to the DIAGNOST 73, which is a pre-amendment device. The intended use of the Philips EasyDIAGNOST is the same as for the Philips DIAGNOST 76 plus. Both systems make use of equivalent technology.

# SAFETY INFORMATION:

Throughout the world, R/F systems are indispensable in daily practice for routine X-ray diagnosis. Industry and users have many years of experience with this type of equipment. The Philips EasyDIAGNOST uses mature technology and is designed to be in compliance with National and International safety standards.

The software used in the EasyDIAGNOST is equivalent to the software used in the predicate device.

The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the device is of minor level of concern, as per the August 29, 1991 issue of the "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".

Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence.