PHILIPS DUO DIAGNOST

K983069 · Philips Medical Systems North America, Inc. · OWB · Nov 2, 1998 · Radiology

Device Facts

• Record ID: K983069
• Device Name: PHILIPS DUO DIAGNOST
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: OWB · Radiology
• Decision Date: Nov 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Philips DUO DIAGNOST is a multi-functional diagnostic X-Ray system intended for Fluoroscopic. Radiographic, Angiographic, and Interventional applications.

Device Story

Remote-controlled multi-functional radiographic/fluoroscopic (R/F) system; consists of floor-mounted tilting patient support table, undertable spotfilm device, image intensifier, TV camera, and overtable X-Ray tube on floor/wall-stand. X-Ray tube mechanically couples to table for fluoroscopy/spot film; radiography performed in coupled or uncoupled modes. System includes X-Ray generator, trimode image intensifier, XTV imaging system, X-Ray tube, and TV monitors. Optional components include multiformat camera (PMI 100), wallbucky stand, and digital spot film camera. Operated by clinicians in clinical settings. Provides real-time fluoroscopic visualization and static radiographic images to assist in diagnostic and interventional procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and compliance with established safety and performance standards.

Technological Characteristics

Remote-controlled R/F system. Components: tilting patient support table, undertable spotfilm device, trimode image intensifier, TV camera, X-Ray generator, X-Ray tube (glass or metal), TV monitors. Connectivity: optional digital spot film camera. Safety standards: 21 CFR 1020.30-32, UL 2601-1, IEC 60601-1, IEC 60601-2-7, IEC 60601-2-32.

Indications for Use

Indicated for diagnostic imaging in radiographic, fluoroscopic, angiographic, and interventional applications. Patient population not specified.

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

• Philips Diagnost 96 (K912470)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the Philips logo. The logo is a shield shape with the word "PHILIPS" at the top. Inside the shield, there are wavy lines and plus signs. The logo is black and white.

**PHILIPS**

## Philips Medical Systems

# 510(k) Summary

K983069

| Company name: | Philips Medical Systems North America Company |
|----------------------|----------------------------------------------------|
| Address: | 710 Bridgeport Avenue. Shelton, CT 06484 |
| Contact person: | Peter Altman |
| Telephone number: | 203-926-7031 |
| Prepared: | August 31, 1998 |
| Device name: | Philips DUO DIAGNOST |
| Classification name: | Fluoroscopic X-Ray System, 90JAA, 21 CFR 892.1680 |
| Common/Usual name: | Remote-controlled Radiographic/Fluoroscopic System |
| Predicate Device(s): | Philips Diagnost 96 |

### Intended use:

The Philips DUO DIAGNOST is a multi-functional diagnostic X-Ray system intended for Fluoroscopic. Radiographic, Angiographic, and Interventional applications.

#### System description:

The Philips DUO DIAGNOST is a remote controlled multi-functional R/F system consisting of a floor-mounted tilting patient support table and an undertable spotfilm device holding an image intensifier and the TV camera. The overtable X-Ray tube is supported by a combined floor/wall-stand. The X-Ray tube can be mechanically coupled to the table for fluoroscopy or spot film work and Radiography is possible in the coupled or uncoupled The system comes with an X-Ray generator, trimode Image Intensifier, XTV mode. imaging system. Philips glass or metal X-Ray tube, and TV monitor(s). An optional multiformat camera (PMI 100) can also be added, as can a wallbucky stand, and digital spot film camera.

### Substantial equivalence Information

The DUO DIAGNOST is substantially equivalent to the Philips Diagnost 96 system (FDA ref. K912470).

#### Safety Information

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 2601-1, IEC 60601-1. IEC 60601-2-7, IEC 60601-2-32). The Information for Users contains comprehensive information to insure safe and effective use.

Philips Medical Systems
North America Company
710 Bridgeport Avenue
P.O. Box 860
Shelton, Connecticut 06484-0917
Tel: [phone]
Fax: [phone]

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, in a dark blue color. The profiles are arranged to suggest a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

AUG 23 2013

Mr. Peter Altman Director of Regulatory Affairs Philips Medical Systems 710 Bridgeport Avenue SHELTON CT 06484

Re: K983069

Trade/Device Name: Philips DUO Diagnostic R/F Table Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: September 1, 1998 Received: September 2, 1998

Dear Mr. Altman:

This letter corrects our substantially equivalent letter of November 2, 1998.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR). Parts 800 to 895. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); medical device reporting of

{2}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ -Unknown K983069

Philips DUO DIAGNOST Device Name :

Indications For Use :

The Philips DUO DIAGNOST is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Sejerson
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number

Prescription Use ( Per 21 CFR 801.109 OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)