CENTERLINE BIOMEDICAL, INC.

Address:10000 Cedar Avenue,Cleveland,OH,44106,US

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- Catalog Number : MC-1

Device Description : The IOPS (Intra-Operative Positioning System) is intended for the evaluation of 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.

Device Class : 2

Duns Number: 080088507

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

- Catalog Number : SCC-1

Device Description : IOPS™ Catheter Simple Curve 1

Device Class : 2

Duns Number: 080088507

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

- Catalog Number : RCC-1

Device Description : IOPS™ Catheter Reverse Curve 1

Device Class : 2

Duns Number: 080088507

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

- Catalog Number : SSH-1

Device Description : IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system

Device Class : 2

Duns Number: 080088507

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

- Catalog Number : ATW-2

Device Description : IOPS™ Guidewire 2

Device Class : 2

Duns Number: 080088507

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

- Catalog Number : TP-1

Device Description : IOPS™ Tracking Pad 1

Device Class : 2

Duns Number: 080088507

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

- Catalog Number : SW-1

Device Description : The IOPS (Intra-Operative Positioning System) is intended for the evaluation of 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.

Device Class : 2

Duns Number: 080088507

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1