MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CapsoCam Plus (SV-3) Capsule Endoscopy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MiroCam Capsule Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RAPID Web

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MIROCAM CAPSULE ENDOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Olympus Small Intestinal Capsule Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NaviCam Small Bowel Capsule Endoscopy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CapsoCam Plus (SV-3)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CapsoCam Plus (SV-3) Capsule Endoscopy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CapsoCam (SV-1)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology