Spectral CT— 510(k) K244008
Substantially EquivalentPhilips 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
- Product 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
- Haifa, IL
Recent devices under product code JAK
view allMore clearances from Philips Medical Systems Technologies , Ltd.
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 K244008
K-number listed on FDA's recall record- Z-0078-2027 — Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.);
- Z-3155-2026 — Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
- Z-1317-2026 — Spectral CT; Product Code (REF): 728333;
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.