System, Imaging, Esophageal, Wireless, Capsule

Product Code: NSI

Gastroenterology/Urology Microwave Medical Products

Definition: The Capsule Is A Disposable, Ingestible Capsule Designed To Acquire Video Images Of The Esophagus. The Capsule Transmits The Acquired Images Via Rf Communication Channel To A Data Recorder Located Outside The Body. The Diagnostic Imaging System Is Intended For Visualization Of The Esophagus Rather Than The Small Bowel.

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

Code of Federal Regulations: 876.1300


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as NSI

2044System, Imaging, Esophageal, Wireless, CapsuleIngestible Telemetric Gastrointestinal Capsule Imaging System.

Total Product Life Cycle (TPLC) Devices

2044System, Imaging, Esophageal, Wireless, CapsuleIngestible Telemetric Gastrointestinal Capsule Imaging System.

Pre-market Notifications for NSI

K180171PillCam Patency SystemGiven Imaging Ltd.
K090557GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEMGIVEN IMAGING LTD.
K071153GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULEGIVEN IMAGING LTD.
K060805MODIFICATION TO GIVEN DIAGNOSTIC SYSTEMGIVEN IMAGING LTD.
K052184GIVEN DIAGNOSTIC SYSTEMGIVEN IMAGING LTD.
K042960GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESOGIVEN IMAGING LTD.
K041149GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULEGIVEN IMAGING LTD.

Global Unique Device Identification Database

07290101363200SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE

Maude Adverse Events

SMALL BOWEL CAPSULE RECORDER SB3MEDTRONIC INC. / GIVEN IMAGING LTD.2020-03-26
PILLCAMGIVEN IMAGING LTD., YOQNEAM2019-06-28
PILLCAMGIVEN IMAGING LTD., YOQNEAM2019-03-28
PILLCAMGIVEN IMAGING LTD., YOQNEAM2019-03-14
UNKNOWN-BRAVOGIVEN IMAGING LTD., YOQNEAM2018-12-27
UNKNOWN-BRAVOGIVEN IMAGING LTD., YOQNEAM2018-12-27
UNKNOWN-BRAVOGIVEN IMAGING LTD., YOQNEAM2018-12-27
PILLCAMGIVEN IMAGING INC.2018-11-09
MEDTRONIC PILLCAM DR3 RECORDERGIVEN IMAGING, INC.2018-11-09
PILLCAMGIVEN IMAGING, INC.2018-11-09
PILLCAMGIVEN IMAGING LTD., YOQNEAM2018-11-08
PILLCAMGIVEN IMAGING LTD., YOQNEAM2018-11-02
PILLCAMGIVEN IMAGING LTD., YOQNEAM2018-10-01
PILLCAMGIVEN IMAGING LTD., YOQNEAM2018-09-27
PILLCAMGIVEN IMAGING LTD., YOQNEAM2018-09-18
PILLCAMGIVEN IMAGING, INC.2018-09-07
PILLCAMGIVEN IMAGING, INC.2018-08-29
PILLCAMGIVEN IMAGING LTD., YOQNEAM2018-06-20
PILLCAMGIVEN IMAGING LTD., YOQNEAM2018-04-17
PILLCAM? PATENCY CAPSULEGIVEN IMAGING LTD., YOQNEAM2017-10-23
PILLCAM PATENCY CAPSULE, 5-PACKGIVEN LTD (ISRAEL)2016-11-17
DR3 DATA RECORDERGIVEN/MEDTRONIC2016-07-07
PILLCAMGIVEN IMAGING, INC.2016-01-25
P/CAM PATENCY CAPL 1-PKGIVEN LTD (ISRAEL)2015-11-17
PILLCAM RECORDERGIVEN IMAGINING2014-12-30
DR2CGIVEN IMAGING, INC.2014-01-15
GIVEN IMAGINGGIVEN IMAGING2012-01-11
OLYMPUS AMERICA, INC.OLYMPUS AMERICA, INC.2010-10-21
PILLCAM SB CAPSULEGIVEN IMAGING, LTD.2009-11-19
PILLCAMGIVEN IMAGING, INC.2005-05-23
PILLCAMGIVEN IMAGING INC2005-02-14
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