510(k) Report

Devices descending from K230991

1 later device reach PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)20240—