Spectral CT— 510(k) K244008

Name: FDA 510(k) clearance K244008
Creator: U.S. Food and Drug Administration
Published: 2025-05-16

Substantially Equivalent

Philips Medical Systems Technologies , Ltd.

FDA 510(k) clearance K244008 for Spectral CT, Substantially Equivalent on 2025-05-16. Applicant: Philips Medical Systems Technologies , Ltd.. Device class: 2.

Clearance details

Applicant: Philips Medical Systems Technologies , Ltd.
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2024-12-26
Decision date: 2025-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAK

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K253450 — BodyTom Elite (NL4000)2026-07-28
K253770 — CardIQ Suite2026-07-21
K253560 — Enhanced Boundary for PCCT2026-06-24
K253026 — Respiratory Gating for Scanners (2.1)2026-06-04
K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.02026-05-20

More clearances from Philips Medical Systems Technologies , Ltd.

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K253649 — Spectral CT Verida Family2026-03-27
K240844 — Spectral CT 7500 RT2024-10-18
K173588 — Illumeo System2018-01-12

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K244008

K-number listed on FDA's recall record

Z-1317-2026 — Spectral CT; Product Code (REF): 728333;Class II·Ongoing·Philips North America Llc·20260107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K244008.

Data sourced from openFDA. This site is unofficial and independent of the FDA.