← Product Code [KPR](/productcode/KPR) · K982824 # X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID (K982824) _I.E.D., Inc. · KPR · Oct 29, 1998 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K982824 ## Device Facts - **Applicant:** I.E.D., Inc. - **Product Code:** [KPR](/productcode/KPR.md) - **Decision Date:** Oct 29, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1680 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use To control the X-Ray on time exposure ## Device Story X-Ray Timer (Models IED7881, IED7888, IED #B7641D) functions as a component for radiological equipment. Device controls duration of X-ray exposure; ensures precise timing for diagnostic imaging procedures. Operated by radiology technicians or physicians in clinical environments. Output consists of electrical signal to terminate X-ray emission after preset interval. Benefits include standardized exposure times, reduced radiation risk from overexposure, and improved image consistency. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Electronic timer for X-ray equipment; controls exposure duration. Class II device (21 CFR 892.1680, Procode KPR). ## 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. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 9 1998 Donald Reilly IED、Inc. 90 Bridge Rd. Islandia, NY 11722 Re: K982824 X-Ray Timer Model # IED7881, IED7888 and IED #B7641D Dated: August 4, 1998 Received: August 11, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR Dear Mr. Reilly: 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 II (Special Controls) or 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 (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 vitm 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/dsma/dsmamam.in.ittm1". Sincerely yours, Lillian Yim, Ph.D. 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 {1}------------------------------------------------ i'ape l'app! ಿ 510(k) 1- umber (if known): x-Ray Timer Model #'s_IED7881, IED7888 and IED #B7641D Device I ame: _ Indicatic :: For Usc: To control the X-Ray on time exposure (PLE/ SE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device: Evaluation (ODE) Umid li. tegm (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number Prescription Use √ (Per 21 C.F.R 801.109) OR Over-The-Counter Use (Upsional Format 1-2-90) --- **Source:** [https://fda-staging.innolitics.com/device/K982824](https://fda-staging.innolitics.com/device/K982824) **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