APPUCANT RAY Co.Ltd / SaftyndEfetiveness Information Software / Z. 711 Ray Co. Ltd. / In Vitro Diagnostics / KI131693 Trade / EMC / Device Name Trade / Korea Manufacturer RAY Co / /
Facility
New Ihiampshire Avenue Document Control Center / / /
IndustryTerm
Internet address httn//~~vwldaL'o/Mcica Dc ics/Rsouccsbr~u/ldusn/dlhut~hmn.Also / announcements concerning your device / predicate devices / predicate device / manufacturing practice requirements / Internet address littp /
MedicalCondition
diseases / /
MusicGroup
Operation / /
Organization
Radiological Health Office / New Ihiampshire Avenue Document Control Center / Division of Postmarket Surveillance / Food and Drug Administration / Division of Small Manufacturers / office of Device Evaluation / CDRJ-I's office of Surveillance / FDA / DEPARTMENT OF HEALTH / Radiological H-ealth Center for Devices and Radiological Health Enclosure Indications for Use / /
Person
Andrewv Paeng / Andrew Paeng / Janine M. Morris / Yun-Jung / Additional Scan / / /
Position
Manager e-mail / HA/Manager / Director / Consultant / /
ProvinceOrState
Maryland / /
Technology
Expert system / radiation / X-ray / X-ray system / digital imaging / /
NOV[removed]k) Submission- RAYSCAN a-Expert Special 510(k) Summary The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part[removed].