True Definition DL— 510(k) K253686
Substantially EquivalentGe Healthcare Japan Corporation
FDA 510(k) clearance K253686 for True Definition DL, Substantially Equivalent on 2026-03-23. Applicant: Ge Healthcare Japan Corporation. Device class: 2.
Summary
Ge Healthcare Japan's True Definition DL is filed under JAK, computed tomography x-ray systems. The record doesn't describe it beyond that name and code name.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Ge Healthcare Japan filed from Hino-Shi, Tokyo, Japan. Review took 122 calendar days (November 21, 2025 to March 23, 2026).
Clearance details
- Applicant
- Ge Healthcare Japan Corporation
- 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
- Hino-Shi, Tokyo, JP
Recent devices under product code JAK
view allMore clearances from Ge Healthcare Japan Corporation
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.