FDA 510(k)

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

K-Number: K240276 · 2024-05-10

ApplicantGiven Imaging Ltd. (D.B.A. Medtronic)

Decision Date2024-05-10

Product CodeNEZ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software is a medical device manufactured by Given Imaging Ltd. (D.B.A. Medtronic). It received FDA 510(k) clearance on 2024-05-10 under approval number K240276. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software?

PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software is a medical device that received FDA 510(k) clearance on 2024-05-10. It is manufactured by Given Imaging Ltd. (D.B.A. Medtronic). The 510(k) number is K240276.

When was PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software approved by the FDA?

PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software received FDA 510(k) clearance on 2024-05-10, under approval number K240276.

What company makes PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software?

PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software is manufactured by Given Imaging Ltd. (D.B.A. Medtronic).

What is the FDA product code for PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software?

The FDA product code for PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software is NEZ.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT04662905 Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain RECRUITING NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 40845310 Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification? JMIR mHealth and uHealth (2025)

Related Devices (Code: NEZ)

K161773CapsoCam Plus (SV-3) Capsule Endoscope SystemCapsoVision, Inc. K151635CapsoCam (SV-1)CapsoVision, Inc. K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging , Ltd. K170839RAPID WebGiven Imaging , Ltd. K163495AdvanCE capsule endoscope delivery deviceUnited States Endoscopy Group, Inc. K163069OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEMOlympus Medical Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.