Philips IntelliSpace Cardiovascular
FDA 510(k) clearance K153022 · decided 2015-11-18
Clearance details
- K-number
- K153022
- Device name
- Philips IntelliSpace Cardiovascular
- Applicant
- Philips Medical Systems Nethrlands BV
- Decision
- Substantially Equivalent
- Date received
- 2015-10-15
- Decision date
- 2015-11-18
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Best Noord-Brabant, NL
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IntelliSpace Cardiovascular, Software 8.0.0.4. recall (Z-2543-2025) | Philips Medical Systems Nederland B.V. | 2025-09-09 |
| IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. recall (Z-1740-2025) | Philips Medical Systems Nederland B.V. | 2025-05-08 |
| Philips IntelliSpace Cardiovascular software, Model 830089. recall (Z-1252-2025) | Philips Medical Systems Nederland B.V. | 2025-02-28 |