Zenition 70— 510(k) K212813
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K212813 for Zenition 70, Substantially Equivalent on 2021-10-01. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nederland B.V.
- 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
- Best Noord-Brabant, NL
Recent devices under product code OWB
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- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)
- K253614 — EchoNavigator R5.0
- K260169 — AV Cardiac CT
Adverse 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 K212813
K-number listed on FDA's recall record- Z-1581-2025 — Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
- Z-0353-2025 — Philips Zenition 70, Model Number: 718133
- Z-0226-2024 — Zenition 50 & 70 Mobile Surgery C-arm
- Z-1583-2025 — Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212813.
Data sourced from openFDA. This site is unofficial and independent of the FDA.