Medtronic O-arm O2 Imaging System— 510(k) K173664
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K173664 for Medtronic O-arm O2 Imaging System, Substantially Equivalent on 2017-12-29. Applicant: Medtronic, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic, Inc.
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Littleton, MA, US
Recent devices under product code OWB
view allMore clearances from Medtronic, Inc.
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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 →
Recalls naming K173664
K-number listed on FDA's recall record- Z-0767-2020 — O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
- Z-0404-2019 — Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173664.
Data sourced from openFDA. This site is unofficial and independent of the FDA.