Philips iCT CT System— 510(k) K162838
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K162838 for Philips iCT CT System, Substantially Equivalent on 2017-04-07. 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 K162838
K-number listed on FDA's recall record- Z-2598-2025 — Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
- Z-2314-2021 — 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
- Z-2189-2019 — iCT, Model # 728306, computed tomography x-ray system
- Z-2190-2019 — iCT SP Model # 728311, computed tomography x-ray system
- Z-1144-2019 — Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
- Z-0388-2018 — Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162838.
Data sourced from openFDA. This site is unofficial and independent of the FDA.