← Product Code [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK) · K053210 # MAYFIELD SCANMATE MOBILE CT SYSTEM (K053210) _Schaerer Mayfield USA, Inc. · JAK · Jan 6, 2006 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K053210 ## Device Facts - **Applicant:** Schaerer Mayfield USA, Inc. - **Product Code:** [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK.md) - **Decision Date:** Jan 6, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1750 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The Mayfield® ScanMate™ Mobile CT System is a whole body CT scanning system. It is intended for use as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. ## Device Story Mayfield® ScanMate™ Mobile CT System is a mobile whole-body CT scanner. Device utilizes a translatable rotating disk containing an X-ray generator and tube to acquire X-ray transmission data from multiple angles. System performs computer reconstruction of acquired data to produce cross-sectional diagnostic images. Intended for clinical use by healthcare professionals to assist in diagnostic decision-making. Mobile form factor allows for point-of-care imaging. ## Technological Characteristics Mobile whole-body CT system; translatable rotating disk architecture; X-ray generator and tube assembly; computer-based image reconstruction of X-ray transmission data. ## Regulatory Identification A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. ## Predicate Devices - Analogic Corporation's ANATOM 2000 ## 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}------------------------------------------------ # KoS3210 #### JAN G 2006 510(k) SUMMARY Schaerer Mayfield USA, Inc.'s Mayfield® ScanMate™ Mobile CT System ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Schaerer Mayfield USA, Inc. 4900 Charlemar Drive Cincinnati, OH 45227 Phone: (513) 561-2241 Facsimile: (513) 561-0195 Contact Person: Teck W. Awa Date Prepared: November 1, 2005 ## Name of Device and Name/Address of Sponsor Mayfield® ScanMate™ Mobile CT System Schaerer Mayfield USA, Inc. 4900 Charlemar Drive Cincinnati, OH 45227 ### Common or Usual Name Computed Tomography X-ray System ### Classification Name Computed Tomography X-ray System #### Predicate Device(s) Analogic Corporation's ANATOM 2000 # Intended Use / Indications for Use The Mayfield® ScanMate™ Mobile CT System is a whole body CT scanning system. It is intended for use as a Computed Tomography X-ray Sus on for diagnostic purposes, producing cross-sectional images of the body through computer {1}------------------------------------------------ econstruction of X-ray transmission data from the same axial plane taken at different angles. yfield® ScanMate™ Mobile CT S Tomography X-ray System for diagnostic purposes, production mages of the body through computer reconstruction of X-ray tra on the samharial prisotten at different angles. The samharial prises es a translatable rotating disk with X-ray generator and tube, pre TM Mobile 0M 2000. The Mayfield® ScanMate™ Mobile CT System 1s as ses, indications for use, technological characteristics, and principles of n as its predicate device, ecomicrogical charactcrisites, and primetples of as its predicate device, except that the ScanMate Mobile CT System uses adolocal expressor a concernal more de market monie CT System des hoologia Alfare Proventus montant and more of President Proven need Trans and Proven Hana de Hostine Portug {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Schaerer Mayfield USA, Inc. % Mr. Jeffrey K. Shapiro Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004 Re: K053210 2006 JAN 6 Trade/Device Name: Mayfield® ScanMate™ Mobile CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 16, 2005 Received: November 16, 2005 Dear Mr. Shapiro: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 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: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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}------------------------------------------------ ### · Indications for Use Statement 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Mayfield® ScanMate™ Mobile CT System Indications for Use: The Mayfield® ScanMate™ Mobile CT System is intended for use as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Prescription Use __ X_ (Part 21 C.F.R. 801 Subpart D) AND/OR Over-The-Counter Use_ (21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page _____ of David A. Lyon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __ \\\DC - 24236/0001 - 2212551 v 1 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K053210](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K053210) **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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