VERADIUS UNITY— 510(k) K142708
Substantially EquivalentPhilips Medical Systems Nethrlands BV
FDA 510(k) clearance K142708 for VERADIUS UNITY, Substantially Equivalent on 2014-10-22. Applicant: Philips Medical Systems Nethrlands BV. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nethrlands BV
- 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
- Abbreviated
- Location
- Best Noord-Brabant, NL
Recent devices under product code OWB
view allMore clearances from Philips Medical Systems Nethrlands BV
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 K142708
K-number listed on FDA's recall record- Z-1582-2025 — Veradius Unity. Product Code 718132. 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-0230-2024 — Veradius Unity Mobile Surgery C-arm
- Z-0649-2022 — Veradius Unity, Model #718132
- Z-0357-2022 — Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142708.
Data sourced from openFDA. This site is unofficial and independent of the FDA.