PHILIPS MODEL MX 16 SLICE CT SYSTEM— 510(k) K083498
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K083498 for PHILIPS MODEL MX 16 SLICE CT SYSTEM, Substantially Equivalent on 2008-12-17. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.
Clearance details
- Applicant
- Philips 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
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code JAK
view allMore clearances from Philips Medical Systems (Cleveland), Inc.
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 K083498
K-number listed on FDA's recall record- Z-0190-2015 — MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Access Dual CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles.
- Z-0019-2014 — MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
- Z-0899-2013 — Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
- Z-2386-2012 — MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083498.
Data sourced from openFDA. This site is unofficial and independent of the FDA.