DOSERIGHT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, sans-serif font, placed above a shield-like shape. Inside the shield, there are wavy lines representing radio waves, and stars are scattered around the waves. The logo is black and white. Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in bold, black letters against a white background. The font is sans-serif and appears to be slightly distressed, giving it a vintage or worn look. The letters are large and fill most of the frame, making the word easily readable. OCT = 1 2001 ## Philips Medical Systems KO12238 # 510(K) Summary In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a 510(K) summary of safety and effectiveness for the following device. | SUBMITTER NAME / ADDRESS: | Philips Medical Systems North America Company<br>710 Bridgeport Avenue<br>Shelton, CT 06484-0917 | |---------------------------|--------------------------------------------------------------------------------------------------| | CONTACT PERSON / TEL NO: | Peter Altman, Director of Regulatory Affairs<br>Tel No: (203) 926-7031 | | DATE SUMMARY PREPARED: | July 16, 2000 | | ESTABLISHMENT NO .: | 1217116 | | CLASSIFICATION NAME: | Computed Tomography X-ray System<br>(21 CFR 892.1750; Class II; Tier 2; 90JAK) | | COMMON/USUAL NAME: | Option for CT X-ray System | | TRADE/PROPRIETARY NAME: | DoseRight | | PREDICATE DEVICE(S): | SmartScan option to the HiSpeed CT/I CT System:<br>manufactured by GE Medical Systems | ### DEVICE DESCRIPTION: DoseRight is a software option to the Philips CT Vision product family of computed tomography systems. The CT Vision products are whole body scanners. The CT Vision product family is comprised of the following systems. Each product has been cleared for commercial distribution via the referenced 510(k) submission. - · Philips CT Secura (previously named Tomoscan AV-NT, ref: K991278) - · Philips CT Secura MV (ref: K000819) - · Philips CT Aura (previously named Tomoscan CS, ref: K982631) DoseRight is used to enable automatic dose regulation during scanning for the purpose of obtaining the desired image quality at the lowest possible dose. Using DoseRight, the dose required to attain a pre-determined image quality is calculated from the scanogram (scanned projection radiograph) of the patient and resultant scan parameters are then recommended to the user for the scan protocol. The user performs the scanogram in the normal way. At the comletion of the scanogram, and with DoseRight enabled, a mAs/KV combination is displayed to the user, which is the recommended combination to use in the scan protocol to achieve a pra-determined user defined image quality relative to patient diameter. However, if the user so chooses, this recommendation can be ignored and the user can proceed with the standard protocol. > Phillios Medical Systems North America Company 472 Wheelers Farm Road P.O. Box 3828 Milford, Connecticus 06460 03 \ 926-767 Fax: (203) 783-3060 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a logo for Philips. The logo is a shield shape with the word "PHILIPS" written at the top. Inside the shield, there are four stars arranged in a square pattern, with a wavy line in the center. The logo is black and white. #### INTENDED USE DoseRight is intended to be used for automatic dose regulation during CT scanning for the purpose of obtaining the desired image quality at the lowest possible dose. DoseRight is a software option to the CT Vision family of CT systems. These systems are whole body Computed Tomography (CT) systems which are diagnostic X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission of data from the same axial plane taken at different angles. They includes signal analysis and display equipment, patient and equipment supports, component parts and accessories which are used in combination with signal and image processing software to facilitate the relative localization of anatomy with gray-scale representation of density relative to water utilizing Houndsfield indices with or without contrast mediums. They are used for the display, storage and analysis of digital diagnostic CT images. They are intended for use by a physician in the diagnosis and planning phases of patient conditions and treatment. #### SUBSTANTIAL EQUIVALENCE INFORMATION: The DoseRight option is considered comparable and substantially equivalent to the following predicate device. - · SmartScan Option used in GE Medical System's HiSpeed CT/i CT System (ref: K964746) The above-mentioned CT system has been cleared for commercial distribution via the referenced 510(k) submission. #### SAFETY INFORMATION: The DoseRight option introduces no new safety issues to the CT Vision family of CT systems other then those already known with these systems in which this type option is used. Computed tomography is a mature technology with which industry and users have many years of experience. These devices must comply with the appropriate sections of the Radiation Control for Health and Safety Act. The DoseRight option as part of the CT Vision family of CT systems and its associated labeling complies with the applicable requirements of the Federal X-ray Performance standards 21CFR 1020.30, 1020.33. The Philips CT Vision family of CT systems with which the DoseRight option is used are designed to comply with the requirements of Underwriters Laboratories (UL) Standard for Safety of Medical Electrical Equipment (UL-2601) and be classified by Underwriters Laboratories or an equivalent test laboratory. They are also designed to comply with the requirements of IEC-601-1 (Medical Electrical Equipment). The results of the hazard analysis, combined with the appropriate preventive measures taken indicate that the device is of minor level of concern as per the August 29, 1991 issue of the "Reviewer's Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review". {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal features an abstract eagle with three stripes on its back, symbolizing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. d and Drug Administration 00 Corporate Boulevard ockville MD 20650 OCT - 1 2001 Mr. Frank Gianelli Senior Regulatory Affairs Specialist Philips Medical Systems North America 710 Bridgeport Avenue P.O. Box 860 SHELTON CT 06484-0917 Re: K012238 Trade/Device Name: DoseRight_ Option for CT X-ray System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: 90 JAK Dated: July 16, 2001 Received: July 17, 2001 Dear Mr. Gianelli: We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 3 ro(t) premium is substantially equivalent (for the indications referenced above and have determined the device is substantially equivalent (fo ferenced above and nave decemined the arroed predicate devices marketed in interstate for use stated in the encrosule) to regally manat date of the Medical Device Ameradments, or to commerce prior in May 26, 1776, the enaother with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, dietelore, market the device, but jeer of and of engistration, listing of general controls provisions of the rict labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classined (500 a00 v) ... Existing major regulations affecting your device can be it may be sunfect to additional condois. Extrems, Title 21, Parts 800 to 898. In addition, FDA may found in the Ood of I occal Regaring your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean I rease of advised that I Dr 3 rossance or our device complies with other requirements of the Act that I DA has made a decorminations administered by other Federal agencies. You must of any Federal Statutes and regulations annualing, but not limited to: registration and listing comply with and not 110. 5 requences Part 801); good manufacturing practice requirements as set (21 ℃FR Part 807), laborang (21 Cegulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) rogusations 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name : Indications For Use : DoseRight is intended to be used for automatic dose regulation during CT scanning for the purpose of obtaining the desired image quality at the lowest possible dose. DoseRight is a software option to the CT Vision family of CT systems. These systems are whole body Computed Tomography (CT) systems which are diagnostic X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission of data from the same axial plane taken at different angles. They includes signal analysis and display equipment, patient and equipment supports, component parts and accessories which are used in combination with signal and image processing software to facilitate the relative localization of analomy with gray-scale representation of density relative to water utilizing Houndsfield indices with or without contrast mediums. They are used for the display, storage and analysis of digital diagnostic CT images. They are intended for use by a physician in the diagnosis and planning phases of patient conditions and treatment. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | |------------------------| | ( Per 21 CFR 801.109 ) | Over-The-Counter Use Nancy C. Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K012238 OR (Optional Format 1-2-96)