SmartCT (R3.0 (L10))— 510(k) K253670
Substantially EquivalentPhilips Medical Systems B.V.
FDA 510(k) clearance K253670 for SmartCT (R3.0 (L10)), Substantially Equivalent on 2026-07-10. Applicant: Philips Medical Systems B.V.. Device class: 2.
Summary
Philips Medical Systems' SmartCT (R3.0 (L10)) is filed under OWB, interventional fluoroscopic X-ray systems. The name carries a release designation, R3.0 (L10), and the record doesn't describe what the product does beyond that code name.
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel, and it came in as an Abbreviated 510(k).
Philips filed from Best, Netherlands. Review took 231 calendar days (November 21, 2025 to July 10, 2026).
Clearance details
- Applicant
- Philips Medical Systems B.V.
- Product code
- Product 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, NL
Recent devices under product code OWB
view allMore clearances from Philips Medical Systems B.V.
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.