Philips Spectral CT Applications— 510(k) K150665
Substantially EquivalentPhilips Medical Systems Nethrlands BV
FDA 510(k) clearance K150665 for Philips Spectral CT Applications, Substantially Equivalent on 2015-08-07. Applicant: Philips Medical Systems Nethrlands BV. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nethrlands BV
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Best Noord-Brabant, NL
Recent devices under product code JAK
view allMore clearances from Philips Medical Systems Nethrlands BV
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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 K150665
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150665.
Data sourced from openFDA. This site is unofficial and independent of the FDA.