System, Imaging, Gastrointestinal, Wireless, Capsule

Product Code: NEZ

Gastroenterology/Urology General Optical Products / Medical

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 876.1300


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as NEZ

2015System, Imaging, Gastrointestinal, Wireless, CapsuleIngestible Telemetric Gastrointestinal Capsule Imaging System.

Total Product Life Cycle (TPLC) Devices

2015System, Imaging, Gastrointestinal, Wireless, CapsuleIngestible Telemetric Gastrointestinal Capsule Imaging System.

Pre-market Notifications for NEZ

K221590NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co., Ltd.
K211684PillCam SB 3 Capsule Endoscopy System, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)
K192662CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.
K183192CapsoCam Plus (SV-3)CapsoVision, Inc.
K183053Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp.
K180732MiroCam Capsule Endoscope SystemIntroMedic Co., Ltd.
K173459Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp.
K170839RAPID WebGiven Imaging Ltd.
K170438MiroCam Capsule Endoscope SystemIntroMedic Co., Ltd.
K170210PillCam SBC Capsule Endoscopy System, PilCam Desktop Software 9.0Given Imaging Ltd.
K163495AdvanCE Capsule Endoscope Delivery DeviceUnited States Endoscopy Group, Inc.
K163069OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEMOLYMPUS MEDICAL SYSTEMS CORP.
K161773CapsoCam Plus (SV-3) Capsule Endoscope SystemCapsoVision, Inc
K151635CapsoCam (SV-1)CapsoVision, Inc.
K143663MiroCam Capsule Endoscope SystemINTROMEDIC CO., LTD

Global Unique Device Identification Database

10816765011185SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
00867770000247System, Imaging, Gastrointestinal, Wireless, Capsule
00867770000230System, Imaging, Gastrointestinal, Wireless, Capsule
00867770000216System, Imaging, Gastrointestinal, Wireless, Capsule
00867770000209System, Imaging, Gastrointestinal, Wireless, Capsule
07290110360825SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
07290110360818SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
07290110360719SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
07290110360566SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
07290110360559SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
07290110360542SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
07290110360436SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
07290110360429SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
07290110360368SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
07290110360344SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Maude Adverse Events

PILLCAMGIVEN IMAGING2020-03-26
PILLCAMGIVEN IMAGING LTD., YOQNEAM2020-03-25
BRAVOGIVEN IMAGING, INC.2020-03-18
PILLCAMGIVEN IMAGING LTD., YOQNEAM2020-03-18
UNKNOWN PILLCAMGIVEN IMAGING LTD., YOQNEAM2020-03-17
PILLCAMGIVEN IMAGING LTD., YOQNEAM2020-03-16
PILLCAMGIVEN IMAGING LTD., YOQNEAM2020-03-09
PILLCAM RECORDER DR3GIVEN IMAGING, INC.2020-02-05
PILLCAMGIVEN IMAGING LTD., YOQNEAM2020-01-28
PILLCAMGIVEN IMAGING LTD., YOQNEAM2020-01-22
ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICEUNITED STATES ENDOSCOPY GROUP, INC.2020-01-16
MIROCAM CAPSULE ENDOSOPE SYSTEMINTROMEDIC CO.,LTD.2020-01-14
UNKNOWN PILLCAMGIVEN IMAGING LTD., YOQNEAM2020-01-07
UNKNOWN PILLCAMGIVEN IMAGING LTD., YOQNEAM2020-01-03
PILLCAMGIVEN IMAGING LTD., YOQNEAM2020-01-02
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-27
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-26
PILLCAMGIVEN IMAGING LTD., YOQNEAM2019-11-26
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-25
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-25
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-22
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-22
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-22
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-22
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-22
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-21
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-20
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-20
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-18
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-17
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-14
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-13
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-13
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-13
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-13
PILLCAMGIVEN IMAGING LTD., YOQNEAM2019-11-12
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-11
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-08
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-07
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-07
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-07
PILLCAMGIVEN IMAGING LTD., YOQNEAM2019-11-04
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-01
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-11-01
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-10-29
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-10-29
CAPSULE, GIUNITED STATES ENDOSCOPY GROUP, INC.2019-10-29
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-10-28
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-10-28
BRAVOGIVEN IMAGING LTD., YOQNEAM2019-10-25
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