510(k) K254120
- Device
- SubtleHD-CT (1.x)
- Applicant
- Subtle Medical, Inc.
- 510(k) number
- K254120
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-15
- Date received
- 2025-12-19
- Regulation
- 892.2050
- Classification name
- Automated Radiological Image Processing Software
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Alese Devin
- Address
- 883 Santa Cruz Ave. Suite 205 Menlo Park CA US 94025 94025
FDA Registration Numbers
- 3018302800
- 3025602618
- 3009731198
- 3023217364
- 9710602
- 3035950510
- 3032109181
- 3008007310
- 3025110425
- 3001722928
- 3006985147
- 3029923647
- 3009077524
- 3027986210
- 3017210169
- 1644408
- 3036495186
- 3019216
- 3002808157
- 3016446349
- 3032367
- 3020703662
- 3030088963
- 3025603301
- 9614698
- 8041160
- 3030412475
- 3011015597
- 3007194257
- 3013497030
- 3014809646
- 3014310698
- 3033527283
- 9680825
- 9617277
- 3042248552
- 3010656400
- 3026970882
- 3021887566
- 9611125
- 3002619337
- 3031569584
- 3015516266
- 3019541896
- 3007545404
- 3006165260
- 3027645731
- 3024972425
- 3016824824
- 3028006458
- 3035373446
- 3043494619
- 3016461002
- 3004141078
- 3017058304
- 3019878658
- 8020021
- 3020928588
- 1651903
- 3002183074
- 3021032044
- 3005383085
- 3010952312
- 3018733944
- 3039211310
- 1226773
- 1826555
- 3014665798
- 3012747207
- 3011950073
- 3017936680
- 3003594449
- 3023245
- 3014132130
- 3016579137
- 3030446846
- 3007630531
- 3007734888
- 3032807464
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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