IQon Spectral CT— 510(k) K163711
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K163711 for IQon Spectral CT, Substantially Equivalent on 2017-04-05. 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 K163711
K-number listed on FDA's recall record- Z-2601-2025 — Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
- Z-2192-2019 — IQon Spectral CT Model # 728332, computed tomography x-ray system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163711.
Data sourced from openFDA. This site is unofficial and independent of the FDA.