RadLogics, Inc.

CLOSEOUT LETTER RadLogics, Inc. MARCS-CMS 515599 — October 29, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Moshe Becker Recipient Title CEO RadLogics, Inc. 24 Westland Ave. #28 Boston , MA 02115 United States Issuing Office: Office of In Vitro Diagnostics and Radiological Health 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Mr. Becker: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 515599. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Engineering and Quality Center for Devices and Radiological Health Content current as of: 11/05/2019 Regulated Product(s) Medical Devices