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FDA 510(k)

Intra-Operative Positioning System (IOPS) and IOPS Visionary System

K-Number: K263016 · 2026-10-01

ApplicantCenterline Biomedical
Decision Date2026-10-01
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Intra-Operative Positioning System (IOPS) and IOPS Visionary System is the device name listed in this FDA 510(k) record. The listed applicant is Centerline Biomedical. It received FDA 510(k) clearance on 2026-10-01 under 510(k) number K263016. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intra-Operative Positioning System (IOPS) and IOPS Visionary System?

Intra-Operative Positioning System (IOPS) and IOPS Visionary System is a medical device that received FDA 510(k) clearance on 2026-10-01. The listed applicant is Centerline Biomedical. The 510(k) number is K263016.

When did Intra-Operative Positioning System (IOPS) and IOPS Visionary System receive FDA 510(k) clearance?

Intra-Operative Positioning System (IOPS) and IOPS Visionary System received FDA 510(k) clearance on 2026-10-01, under 510(k) number K263016.

Who is the listed applicant for Intra-Operative Positioning System (IOPS) and IOPS Visionary System?

The FDA 510(k) record lists Centerline Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intra-Operative Positioning System (IOPS) and IOPS Visionary System?

The FDA product code for Intra-Operative Positioning System (IOPS) and IOPS Visionary System is DQK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Centerline Biomedical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261729EnSite™ X EP SystemAbbott MedicalK253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK262005Affera Integrated Mapping SystemMedtronic, Inc.K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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.

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