Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)
Centerline Biomedical, Inc.
CENTERLINE BIOMEDICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012154226 | 3012154226 | CENTERLINE BIOMEDICAL | 1 | N | 2026-01-01 | 4535 Renaissance Pkwy Cleveland OH US 44128 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 233590 | 1574061498 | K261329 | Intra-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) | DQK | 2026-06-10 |
| 233590 | 1524100552 | K254089 | IOPS Visionary System (MC-3); 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) | DQK | 2026-02-17 |
| 233590 | 1523532861 | K243842 | Intra-Operative Positioning System (IOPS®) | DQK | 2025-03-06 |
| 233590 | 1566626270 | K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) | DQK | 2024-10-11 |
| 233590 | 1270217633 | K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) | DQK | 2024-07-24 |
| 233590 | 1196614779 | K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) | DQK | 2023-06-21 |
| 233590 | 2056535713 | K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle | DQK | 2019-06-24 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DQK | 7 | 2026-06-10 |
PMN#
Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)
Centerline Biomedical, Inc.
Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)
Centerline Biomedical, Inc.
Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle
Centerline Biomedical, Inc.
GUDID#
IOPS™ Software Application - The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
2020-09-18
IOPS Mobile Cart - The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
2020-09-18
IOPS® - IOPS Fiducial Tracking Pad is a sterile, single use tracking pad intended for use with the Intra-Operative Positioning System (IOPS). It is equipped with a single tracking sensor allowing IOPS to track gross patient motion to allow maintenance of patient registration during a procedure.
2025-03-18
IOPS™ - IOPS™ Tracking Pad 1
2020-09-18
IOPS® - Guidewire Handle
2024-11-11
IOPS Visionary System - The IOPS® Visionary system displays the position and orientation of sensor-equipped IOPS guidewires and IOPS catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously-acquired scan data (CT). IOPS Visionary tracks the location and orientation of the sensors in real time, superimposing navigation of the IOPS Catheter and IOPS Guidewire to the patient's vascular map. The system consists of a surgical navigation technology and a number of associated accessories. The navigation technology is a non-contact, reusable, multi-patient use device. The associated accessories are single use devices provided sterile (EtO). The IOPS Visionary System is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously-acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
2026-02-24
IOPS Viewpoint - Simple Curve Catheter, 75 cm
2024-10-01
IOPS Viewpoint - Double Curve Catheter, 125 cm
2024-10-01
IOPS Viewpoint - Double Curve Catheter, 75 cm
2024-10-01
IOPS Viewpoint - Simple Curve Catheter, 125 cm
2024-10-01
IOPS™ - IOPS™ Catheter Reverse Curve 1
2020-09-18
IOPS™ - IOPS™ Catheter Simple Curve 1
2020-09-18
IOPS™ - Indications for Use: The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.IOPS™ Guidewire 2 is a sensorized wire used to navigate through vasculature to facilitate placement of a catheter. The guidewire is a single-use, externally communicating device that comes into contact with circulating blood for a duration of less than or equal to 24 hours.
2020-09-18
IOPS™ - IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system
2020-10-21
IOPS™ - Indications for Use: The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular intervention in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis. IOPS™ Guidewire 2 is a sensorized wire used to navigate through vasculature to facilitate placement of a catheter. The guidewire is a single-use, externally communicating device that comes into contact with circulating blood for a duration of less than or equal to 24 hours.
2020-09-18
IOPS® - IOPS Fiducial Tracking Pad is a sterile, single use tracking pad intended for use with the Intra-Operative Positioning System (IOPS). It is equipped with a single tracking sensor allowing IOPS to track gross patient motion to allow maintenance of patient registration during a procedure.
2025-03-18
IOPS® - Guidewire Handle
2024-11-11
IOPS Viewpoint - Double Curve Catheter, 125 cm
2024-10-01
IOPS Viewpoint - Double Curve Catheter, 75 cm
2024-10-01
IOPS Viewpoint - Simple Curve Catheter, 125 cm
2024-10-01
IOPS™ - IOPS™ Tracking Pad 1
2020-09-18
IOPS™ - IOPS™ Catheter Reverse Curve 1
2020-09-18
IOPS™ - IOPS™ Catheter Simple Curve 1
2020-09-18
IOPS™ - IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system
2020-10-21