Spectral CT— 510(k) K203020
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K203020 for Spectral CT, Substantially Equivalent on 2021-02-26. 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
Recent devices under product code JAK
view allMore clearances from Philips Medical Systems Nederland B.V.
view all- K254205 — Zenition 30
- K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)
- K253614 — EchoNavigator R5.0
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 K203020
K-number listed on FDA's recall record- Z-2034-2025 — Spectral CT. Computed tomography X-ray system.
- Z-0583-2025 — Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
- Z-1756-2024 — The Oncology Essentials Package of the Spectral CT imaging system.
- Z-1055-2024 — Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
- Z-0725-2024 — Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
- Z-1584-2023 — Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
- Z-2318-2021 — 728333 Spectral CT 7500 -Computed Tomography X-ray system
- Z-1986-2021 — Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203020.
Data sourced from openFDA. This site is unofficial and independent of the FDA.