Intra-Operative Positioning System (IOPS) and IOPS Visionary System— 510(k) K263016
Substantially EquivalentCenterline Biomedical
FDA 510(k) clearance K263016 for Intra-Operative Positioning System (IOPS) and IOPS Visionary System, Substantially Equivalent on 2026-10-01. Applicant: Centerline Biomedical. Device class: 2.
Summary
Centerline Biomedical's Intra-Operative Positioning System (IOPS) and IOPS Visionary System are filed under DQK, programmable diagnostic computers. The record doesn't describe what the systems position or how.
Class II, 21 CFR 870.1425. The Cardiovascular panel reviewed it as a Special 510(k).
Centerline Biomedical filed from Warrensville Heights, Ohio. Review took 34 days (August 28 to October 1, 2026).
Clearance details
- Applicant
- Centerline Biomedical
- Product code
- Product code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warrensville Heights, OH, US
Recent devices under product code DQK
view allMore clearances from Centerline Biomedical
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.