(32 days)
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.
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.
This document is a 510(k) summary for the Philips NICOL Collimator Family. It provides information about the device's intended use and compliance with safety standards, but it does not contain details about acceptance criteria, specific device performance metrics, or any studies involving test sets, ground truth establishment, or human reader performance.
Therefore, I cannot provide the requested information. The provided text is a regulatory submission summary, not a clinical or performance study report.
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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 AvenueShelton, 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: (203) 926-7674 Fax: (203) 929-6099
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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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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)
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
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.(b)
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.