Atlas FDA

NEZ

47 FDA 510(k) clearances · Product code

126 daysmedian time to decision
307 days90th percentile
47clearances measured

FDA profile

Official device name
System, Imaging, Gastrointestinal, Wireless, Capsule
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1300
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 41 · 2022: 63 · 2023: 34 · 2024: 103 · 2025: 69 · 2026: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MiroCam® Capsule Endoscope System (K252617)Intromedic Co., Ltd.2026-05-08
CE Deliver (DLV) (K252480)CapsoVision, Inc.2025-12-19
CapsoCam Plus (SV-3) Capsule Endoscopy System (K242643)CapsoVision, Inc.2024-12-04
PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software (K240276)Given Imaging Ltd. (D.B.A. Medtronic)2024-05-10
NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether (K233229)Anx Robotica Corporation2024-01-05
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (K230991)Given Imaging Ltd. (Medtronic)2023-06-30
NaviCam Small Bowel Capsule Endoscopy System (K221590)Ankon Technologies Co., Ltd.2022-12-02
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (K211684)Given Imaging Ltd. (Medtronic)2021-08-27
CapsoCam Plus (SV-3) Capsule Endoscopy System (K192662)CapsoVision, Inc.2020-02-14
CapsoCam Plus (SV-3) (K183192)CapsoVision, Inc.2019-04-19
Olympus Small Intestinal Capsule Endoscope System (K183053)Olympus Medical Systems Corp.2019-03-05
MiroCam Capsule Endoscope System (K180732)Intromedic Co., Ltd.2018-11-08
Olympus Small Intestinal Capsule Endoscope System (K173459)Olympus Medical Systems Corp.2018-03-13
MiroCam Capsule Endoscope System (K170438)Intromedic Co., Ltd.2018-01-30
PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 (K170210)Given Imaging , Ltd.2017-09-01
RAPID Web (K170839)Given Imaging , Ltd.2017-05-26
AdvanCE capsule endoscope delivery device (K163495)United States Endoscopy Group, Inc.2017-03-10
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM (K163069)Olympus Medical Systems Corp.2017-01-19
CapsoCam Plus (SV-3) Capsule Endoscope System (K161773)CapsoVision, Inc.2016-10-21
CapsoCam (SV-1) (K151635)CapsoVision, Inc.2016-02-09
MiroCam Capsule Endoscope System (K143663)Intromedic Co., Ltd.2015-03-17
ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT (K142680)Olympus Medical Systems Corp.2015-02-08
GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM (K140284)Given Imaging , Ltd.2014-12-17
MIROCAM CAPSULE ENDOSCOPE SYSTEM (K134005)Intromedic Co., Ltd.2014-07-09
MIROCAM CAPSULE ENDOSCOPE SYSTEM (K140751)Intromedic Co., Ltd.2014-06-30
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM (K123864)Given Imaging , Ltd.2013-08-12
MIROCAM CAPSULE ENDOSCOPE SYSTEM (K123428)Intromedic Co., Ltd.2013-05-20
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM (K123421)Olympus Medical Systems Corp.2013-04-29
MIROCAM CAPSULE ENDOSCOPE SYSTEM (K111450)Intromedic Co., Ltd.2012-05-18
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES (K103025)Given Imaging , Ltd.2011-05-13
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES (K101250)Given Imaging , Ltd.2011-03-07
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT (K103088)Given Imaging , Ltd.2011-01-14
PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE (K101200)Given Imaging , Ltd.2010-09-30
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM (K090210)Olympus Medical Systems Corporation2009-07-29
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT (K091405)Given Imaging , Ltd.2009-07-29
OLYMPUS CAPSULE ENDOSCOPE SYSTEM (K063259)Olympus Medical Systems Corporation2007-09-14
MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM (K070475)Given Imaging , Ltd.2007-05-07
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (K062786)Given Imaging , Ltd.2006-10-18
GIVEN DIAGNOSTIC SYSTEM (K053639)Given Imaging , Ltd.2006-05-08
CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 (K040494)United States Endoscopy Group, Inc.2004-06-23
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (K040248)Given Imaging , Ltd.2004-02-17
GIVEN DIAGNOSTIC SYSTEM (K032405)Given Imaging , Ltd.2003-10-29
GIVEN DIAGNOSTIC SYSTEM (K031033)Given Imaging , Ltd.2003-07-01
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (K022980)Given Imaging , Ltd.2003-02-27
GIVEN DIAGNOSTICS SYSTEM (K022362)Given Imaging , Ltd.2002-08-09
GIVEN DIAGNOSTIC SYSTEM (K020341)Given Imaging , Ltd.2002-05-02
GIVEN DIAGNOSTIC IMAGING SYSTEM (DEN010002)Given Imaging , Ltd.2001-08-01

Track NEZ automatically

Every clearance here is in the API, with alerts when new ones post.