Philips CT Big Bore Sliding Gantry Configuration— 510(k) K181797
Substantially EquivalentPhillips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K181797 for Philips CT Big Bore Sliding Gantry Configuration, Substantially Equivalent on 2018-08-03. Applicant: Phillips Medical Systems (Cleveland), Inc.. Device class: 2.
Clearance details
- Applicant
- Phillips Medical Systems (Cleveland), Inc.
- 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
- Special
- Location
- Cleveland, OH, US
Recent devices under product code JAK
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.