IQon Spectral CT— 510(k) K193454
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K193454 for IQon Spectral CT, Substantially Equivalent on 2020-01-24. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nederland B.V.
- 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
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Adverse 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 K193454
K-number listed on FDA's recall record- Z-3041-2026 — Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
- Z-2651-2026 — IQon Spectral CT IQon Spectral CT Upgrades
- Z-1316-2026 — IQon Spectral CT; Product Code (REF): 728332;
- Z-2317-2021 — 728332 IQon Spectral CT-Computed Tomography X-ray system
- Z-1985-2021 — Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
- Z-1923-2020 — Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193454.
Data sourced from openFDA. This site is unofficial and independent of the FDA.