PHILIPS OMNIDIAGNOST

K982993 · Philips Medical Systems, Inc. · OWB · Sep 29, 1998 · Radiology

Device Facts

• Record ID: K982993
• Device Name: PHILIPS OMNIDIAGNOST
• Applicant: Philips Medical Systems, Inc.
• Product Code: OWB · Radiology
• Decision Date: Sep 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

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

Device Story

OmniDiagnost is a universal, overtable X-ray system for radiographic, fluoroscopic, angiographic, and interventional applications. System utilizes a scanning concept where the column containing the X-ray tube and image intensifier moves while the patient table remains fixed. Components include the OmniDiagnost stand, X-ray generator, X-ray tube, collimator, II-TV subsystem, monitors, control desks, Digital Acquisition System (DSI), and Easy Vision workstation. Operated by clinicians in clinical settings to acquire and visualize diagnostic images. Output assists physicians in clinical decision-making for diagnostic and interventional procedures, potentially benefiting patients through improved diagnostic accuracy and procedural guidance.

Clinical Evidence

Bench testing only. Compliance with 21 CFR 1020.30/.31/.32 and voluntary safety standards (UL 2601) provided to demonstrate safety and effectiveness.

Technological Characteristics

Multifunctional overtable X-ray system. Components: X-ray tube, collimator, image intensifier, TV subsystem, digital acquisition system, and workstation. Operates via scanning mechanism with moving column and fixed table. Complies with 21 CFR 1020.30/.31/.32 and UL 2601 safety standards.

Indications for Use

Indicated for patients requiring diagnostic radiographic, fluoroscopic, angiographic, and interventional imaging procedures.

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)

Reference Devices

• Digital Acquisition System (DSI) (K920793)
• Easy Vision (K920950)

Submission Summary (Full Text)

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

SEP 2 9 1999

Image /page/0/Picture/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a sans-serif font above a circular emblem. The emblem contains two wavy lines representing water, with a four-pointed star above and below the wavy lines. The logo is black and white.

# Philips Medical Systems

## 510(k) Summary

| 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 25, 1998 |
| Device name: | Philips OmniDiagnost |
| 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 OmniDiagnost is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.

### System description:

The OmniDiagnost is a multifunctional, universal, overtable X-Ray system offering fluoroscopic, radiographic, angiographic and interventional techniques in a wide variety of applications. The OmniDiagnost employs a scanning concept, whereby the column with X-Ray tube and Image Intensifier moves while the table remains fixed.

The basic system is composed of the OmniDiagnost stand, X-Ray generator, X-Ray tube and collimator, II-TV subsystem and monitors, Control Desks, Digital Acquisition System (DSI (K920793)), and Easy Vision (initially introduced under K920950).

### Substantial equivalence Information

The OmniDiagnost is a modification of, and substantially equivalent to the Philips Diagnost 96 system (FDA ref. K912470).

### Safety Information

The Philips OmniDiagnost complies with the applicable portions of 21 CFR parts 1020.30/.31/.32 and voluntary safety standards, such as UL 2601. 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}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Peter Altman Director of Regulatory Affairs Phillips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Re:

K982993 Philips OmniDiagnost Dated: August 26, 1998 Received: August 27, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 JAA

Dear Mr. Altman:

29 19

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Pederal Food, Drug, and Cosmetic Act (Act). 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 probibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdch/dsmald.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/1/Picture/14 description: The image is a blank white square. There are no objects or figures in the image. The image does not contain any text. The image is completely white.

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

510(k) Number (if known): ______________ Unknown

Philips OmniDiagnost Device Name : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications For Use :

The Philips OmniDiagnost 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)

Gamil A. Siyoum

---

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devic

510(k) Number K982493

Prescription Use
(Per 21 CFR 801.109

14

............

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

l