FDA UDI
In Commercial Distribution
🇺🇸 United States
IOPS™ Software Application
DI: 00843152104000
·
Model: SW-1
·
CENTERLINE BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IOPS™ Software Application
- Primary DI
- 00843152104000
- Version / Model
- SW-1
- Catalog Number
- SW-1
- Company Name
- CENTERLINE BIOMEDICAL, INC.
- Labeler DUNS
- 080088507
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-18
- Public Version
- 3
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- c920598c-1db2-4083-a513-ff6203ce9b1a
Device Description
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 Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58183 | Electromagnetic surgical navigation device tracking system | An assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/spatial markers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843152104000 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190106 | 000 |