Philips IntelliSpace Cardiovascular— 510(k) K153022
Substantially EquivalentPhilips Medical Systems Nethrlands BV
FDA 510(k) clearance K153022 for Philips IntelliSpace Cardiovascular, Substantially Equivalent on 2015-11-18. Applicant: Philips Medical Systems Nethrlands BV. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nethrlands BV
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Best Noord-Brabant, NL
Recent devices under product code LLZ
view allMore clearances from Philips Medical Systems Nethrlands BV
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 K153022
K-number listed on FDA's recall record- Z-2543-2025 — IntelliSpace Cardiovascular, Software 8.0.0.4.
- Z-1740-2025 — IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
- Z-1252-2025 — Philips IntelliSpace Cardiovascular software, Model 830089.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153022.
Data sourced from openFDA. This site is unofficial and independent of the FDA.