FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
True Definition DL
K Number: K253686
·
Decision Mar 23, 2026
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
10
Review Days
122
Basic Information
- Device Name
- True Definition DL
- K Number
- K253686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Healthcare Japan Corporation
- Date Received
- November 21, 2025
- Decision Date
- March 23, 2026
- Product Code
- JAK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAK), ordered by most recent decision date.
Respiratory Gating for Scanners (2.1)
FDA 510(k)
FDA Class 2
·Radiology
Aquilion ONE (TSX-308A/TSX-306A) V2.0
FDA 510(k)
FDA Class 2
·Radiology
Spectral CT Verida Family
FDA 510(k)
FDA Class 2
·Radiology
CT Rembra RT; CT Areta RT; CT Rembra
FDA 510(k)
FDA Class 2
·Radiology
SOMATOM X.cite; SOMATOM X.ceed
FDA 510(k)
FDA Class 2
·Radiology
Photonova Spectra, Photonova Spectra Select
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Ge Healthcare Japan Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K233698 | True Enhance DL | Apr 11, 2024 | Substantially Equivalent |
| K230807 | Deep Learning Image Reconstruction | Apr 20, 2023 | Substantially Equivalent |
| K220961 | Deep Learning Image Reconstruction | Jul 29, 2022 | Substantially Equivalent |
| K213938 | Revolution Ascend | Feb 4, 2022 | Substantially Equivalent |
| K212067 | Deep Learning Image Reconstruction | Sep 17, 2021 | Substantially Equivalent |
| K203169 | Revolution Ascend | Nov 20, 2020 | Substantially Equivalent |
| K193170 | Deep Learning Image Reconstruction | Dec 13, 2019 | Substantially Equivalent |
| K143345 | SIGNA Pioneer | Jul 10, 2015 | Substantially Equivalent |
| K103327 | DISCOVERY MR750W 3.0T | Sep 30, 2011 | Substantially Equivalent |