← Product Code [IXW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW) · K990969 # KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR (K990969) _Konica Medical Corp. · IXW · Jun 18, 1999 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K990969 ## Device Facts - **Applicant:** Konica Medical Corp. - **Product Code:** [IXW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW.md) - **Decision Date:** Jun 18, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1900 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use X-Ray Film Development ## Device Story The SRX-701 is an automatic X-ray film processor used in clinical settings to develop exposed X-ray film. It automates the chemical processing cycle required to produce diagnostic images from film. The device is operated by radiology technicians or clinical staff. By automating film transport through developer, fixer, wash, and dryer sections, it ensures consistent image development, facilitating timely clinical review of radiographic images by physicians for diagnostic purposes. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Automatic X-ray film processor; electromechanical transport system for film processing (developer, fixer, wash, dryer). ## Regulatory Identification An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. ## 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. ## 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}------------------------------------------------ Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 18 1999 Konica Medical Corporation ATTN: Russell D. Munves C/O Storch, Amini & Munves, P.C. The Chrysler Building 405 Lexington Avenue New York. New York 10174 RE: K990969 Konika SRX 701 Automatic X-ray Film Processor Dated: March 22, 1999 Received: March 23, 1999 Regulatory Class: II 21 CFR 892.1900/Procode: 90 IXW Dear Mr. Munves: 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, 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 dass 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 (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 requlatory 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 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/dsmamain.html". Sincerely yours, CAPT 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 {1}------------------------------------------------ 10 Page_1_of_1 510(k) Number (if known):_ Device Name:__SRX-701 Film Processor Indications For Use: X-Ray Film Development (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .. Concurrence of CDRH, Office of Device Evaluation (ODE) Uhind G. Segen (Division Sign-Off) ። Division of Reproductive, Abdominal, ENT, and Radiological Devig 510(k) Number Prescription Use_L (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K990969](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K990969) **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. 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