PHILIPS NICOL COLLIMATOR FAMILY

K990423 · Philips Medical Systems, Inc. · IZW · Mar 15, 1999 · Radiology

Device Facts

• Record ID: K990423
• Device Name: PHILIPS NICOL COLLIMATOR FAMILY
• Applicant: Philips Medical Systems, Inc.
• Product Code: IZW · Radiology
• Decision Date: Mar 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1610
• Device Class: Class 2

Intended Use

The Philips NICOL Collimator is intended for use in diagnostic x-ray systems during radiographic and fluoroscopic examinations. The collimator restricts the dimensions of the diagnostic x-ray field by limiting the size of the primary x-ray beam.

Device Story

The Philips NICOL Collimator is a beam-limiting device for radiographic and fluoroscopic X-ray systems. It functions by mechanically restricting the primary X-ray beam to define the diagnostic field size. The device provides rectangular and circular shuttering, spectral and wedge filtering, light field simulation, and mechanical or electronic source-to-image distance (SID) measurement. It also incorporates dose measurement capabilities. The collimator is operated by healthcare professionals (radiographers, radiologists, or technicians) within clinical imaging environments. By precisely controlling the X-ray beam geometry, the device minimizes patient exposure to ionizing radiation outside the area of clinical interest, thereby improving image quality and enhancing patient safety during diagnostic procedures.

Clinical Evidence

Bench testing only. The device was evaluated for compliance with 21 CFR 1020.30, .31, and .32 (X-ray performance standards) and UL 2601 (Medical Electrical Equipment safety). No clinical data was required or provided.

Technological Characteristics

Beam limiting device for X-ray systems. Features include rectangular/circular shuttering, spectral/wedge filtering, light field simulation, and mechanical/electronic SID measurement. Includes dose measurement. Complies with 21 CFR 1020.30, .31, .32 and UL 2601. Standalone hardware component integrated into radiographic/fluoroscopic systems.

Indications for Use

Indicated for use in diagnostic x-ray systems during radiographic and fluoroscopic examinations to restrict the dimensions of the diagnostic x-ray field by limiting the size of the primary x-ray beam. No specific patient population or contraindications provided.

Regulatory Classification

Identification

A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

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 the limitations in § 892.9.

Predicate Devices

• Philips Galileo Automatic Collimator

Submission Summary (Full Text)

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3/15/99

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## Philips Medical Systems

| Company Name: | Philips Medical Systems North America Company |
|----------------------|------------------------------------------------|
| Address: | 710 Bridgeport Avenue<br>Shelton, CT 06484 |
| Contact Person | Peter Altman |
| Telephone Number: | 203-926-7031 |
| Prepared (date): | February 3, 1999 |
| Device Name: | Philips NICOL Collimator Family |
| Classification Name: | Diagnostic X-ray Beam Limiting Device (90 IZW) |
| Common/Usual Name | Automatic Radiographic Collimator |
| Predicate Device | Philips Galileo Automatic Collimator |

## System Description:

The NICOL collimator family of Beam Limiting Devices which may be used in all Philips Radiographic, Universal Radiographic/Fluoroscopic, Cardio and Vascular systems. It will provide rectangular shuttering, circular shuttering, or a combination of both. It will provide a light simulation of the X-ray field, spectral filtering, wedge filtering, dose measurement, and mechanical or electronic SID measurement.

## Intended Use:

The Philips NICOL Collimator is intended for use in diagnostic x-ray systems during radiographic and fluoroscopic examinations. The collimator restricts the dimensions of the diagnostic x-ray field by limiting the size of the primary x-ray beam.

## Safety Information:

The collimator has been designed to comply with the X-ray performance standard (21 CFR 1020.30, .31, and .32) and with UL 2601, Standard for Safety, Medical Electrical Equipment.

> 10 Bridgeport Avenu elton, Connecticut 06484 Tel: [phone] Fax: [phone]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 ាពុព្

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

Re:

K990423 NICOL Collimator Family Dated: February 4, 1999 Received: February 11, 1999 Regualtory class: II 21 CFR 892.1610/Procode: 90 IZW

Dear Mr. Altman:

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 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). 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 either class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 531 through 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 (21 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 requlation entitled. "Misbranding by reference to premarket notification". 21 CFR 807.97). Other general information on vour 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

CART David J. C. Stclair, M.D.

APT Daniel G. Schultz. M.D. Acting Director. Division of Reproductive. Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): __

Philips NICOL Collimator Family Device Name :

Indications For Use :

The Philips NICOL Collimator is intended for use in diagnostic x-ray systems during radiographic and fluoroscopic examinations. The collimator restricts the dimensions of the diagnostic x-ray field by limiting the size of the primary x-ray beam.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Bergman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K990423

Prescription Use
(Per 21 CFR 801.109

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)