510(k) Report

Devices descending from K101250

12 later devices reach Given Pillcam Platform with Pillcam SB Capsules through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123864Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy SystemGiven Imaging, Ltd.201311—
+2K221590NaviCam Small Bowel Capsule Endoscopy SystemAnkon Technologies Co., Ltd.20220—
+2K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)20213—
+2K170438MiroCam Capsule Endoscope SystemIntromedic Co., Ltd.20182—
+2K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd.20174—
+2K170839RAPID WebGiven Imaging, Ltd.20170—
+2K140284Given Pillcam Ugi Capsule Endoscopy SystemGiven Imaging, Ltd.20140—
+3K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.20240—
+3K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)20231—
+3K180732MiroCam Capsule Endoscope SystemIntromedic Co., Ltd.20181—
+4K252617MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd.20260—
+4K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)20240—