← Product Code [KPR](/productcode/KPR) · K981657 # PHILIPS THORAVISION (K981657) _Philips Medical Systems North America, Inc. · KPR · Jun 18, 1998 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K981657 ## Device Facts - **Applicant:** Philips Medical Systems North America, Inc. - **Product Code:** [KPR](/productcode/KPR.md) - **Decision Date:** Jun 18, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1680 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The Philips Thoravision is intended for use in general radiographic applications wherever conventional screen-film systems may be used. ## Device Story Philips Thoravision is a stationary diagnostic X-ray system originally cleared for chest imaging. This submission extends its use to all general-purpose radiographic examinations. The system functions as a digital radiographic platform; it captures X-ray images and processes them for display. No hardware changes were made; modifications were limited to software updates, specifically the addition of Anatomical Programmed Radiography (APR) settings and adjustments to the user interface screen layout. The device is operated by trained radiology personnel in clinical settings. The output is a digital radiographic image used by clinicians to perform diagnostic examinations across various anatomical regions, replacing the need for conventional screen-film systems. ## Clinical Evidence No clinical data provided; substantial equivalence is based on the minor nature of the modifications to a previously cleared predicate device. ## Technological Characteristics Stationary diagnostic X-ray system. Digital radiographic imaging platform. Software-based APR (Anatomical Programmed Radiography) for various anatomical regions. User interface display for image management. No hardware changes from predicate. ## Regulatory Identification A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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. ## Predicate Devices - Philips Thoravision ([K931071](/device/K931071.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ JUN 18 1998 ( - Image /page/0/Picture/1 description: The image shows the Philips logo, which is a shield shape with the word "PHILIPS" at the top. Inside the shield, there are two wavy lines, a four-pointed star at the bottom, and a cross at the top. The logo is in black and white. # Philips Medical Systems # 510 (k) Summary of Safety and Effectiveness | 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 (date): | May 7, 1998 | | Device Name: | Philips Thoravision | | Classification Name: | Stationary Diagnostic X-ray System
(90 KPR) | | Common/Usual Name | General Purpose X-ray system | | Predicate Device | Philips Thoravision | {1}------------------------------------------------ ### System Description: The Philips Thoravision was submitted as a radiographic system dedicated to chest imaging in 1993. It is now recognized that the system can also be used equally well for examinations of other anatomical areas. This extension to other anatomical areas has required only minor adjustments to the system, primarily in providing APRs addressing those new anatomical areas. As such, the screen layout of the user interface display has changed somewhat. No change has been made to the hardware. #### Intended Use: The Philips Thoravision intended use is being extended from its original use (limited to chest examinations) to include radiographic examinations for all anatomical areas. #### Substantial Equivalence Information: This submission introduces an extension to the Thoravision submitted and cleared under 510(k) K931071. This extension provides the capability to use the Thoravision for all general purpose radiographic examinations in addition to the previously cleared chest examinations. The Philips Thoravision for extended applications is only a minor modification of, and therefore substantially equivalent to, the Philips Thoravision Chest system manufactured by Philips Medical Systems. The Thoravision received 510(k) clearance September 15, 1994 ( see 510(k) K931071). {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, creating a monochrome design. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 8 1998 Peter Altman Director of Regulatory Affairs Philips Medical Systems North*America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, CT 06484-0917 Re: K981657 Philips Thoravision May 8, 1998 Dated: Received: May 11, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR 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 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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (TDA) 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 (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 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.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 {3}------------------------------------------------ ે કેની 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Unknown Philips Thoravision Device Name : Indications For Use : The Philips Thoravision is intended for use in general radiographic applications wherever conventional screen-film systems may be used. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Torit A. Seymm (Division Sign-Off) OR Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number Prescription Use (Per 21 CFR 801.109 ్రామం なんて Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda-staging.innolitics.com/device/K981657](https://fda-staging.innolitics.com/device/K981657) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com