Product code JAK— Radiology
Deep Learning Image Reconstruction
- Advisory panel
- Radiology
- Total cleared
- 820
Adverse 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 →
Recent clearances under product code JAK
1–100 of 820- K253560 — Enhanced Boundary for PCCT
- K253026 — Respiratory Gating for Scanners (2.1)
- K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.0
- K253649 — Spectral CT Verida Family
- K252992 — CT Rembra RT; CT Areta RT; CT Rembra
- K253686 — True Definition DL
- K253520 — Photonova Spectra, Photonova Spectra Select
- K253574 — SOMATOM X.cite; SOMATOM X.ceed
- K252249 — Extremity CT Imaging System
- K260078 — Aquilion ServeSP (TSX-307B) V2.0
- K260166 — Bunkerhill Contrast CAC
- K260167 — Bunkerhill Contrast AVC
- K260169 — AV Cardiac CT
- K253173 — uCT 780 with uWS-CT-Dual Energy Analysis
- K252217 — CT VScore+
- K251805 — syngo.CT Dual Energy
- K250662 — Bunkerhill MAC
- K250766 — LungQ 4
- K251645 — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
- K250928 — OmniTom Elite with PCD
- K251484 — CT:VQ
- K250941 — Revolution Vibe
- K251061 — NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
- K250970 — Marie
- K250822 — SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
- K250648 — Philips iCT CT system
- K243398 — CT Scanner TSX-501R/1 V11.1
- K243672 — CardIQ Suite
- K250370 — SCENARIA View Phase 5.0
- K243617 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
- K244008 — Spectral CT
- K250650 — SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
- K243240 — Vitrea CT VScore
- K242811 — BodyTom 64
- K242411 — Brainomix 360 e-Lung
- K243523 — NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
- K243229 — Bunkerhill AVC
- K241166 — uCT 550
- K241200 — SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
- K241079 — uCT 780
- K241757 — syngo.CT Dual Energy
- K242403 — Aquilion ONE (TSX-308A/3) V1.5
- K242188 — ClearRead CT CAC
- K242874 — Gating Reflector Block
- K240844 — Spectral CT 7500 RT
- K240369 — CAC (gated) Algorithm
- K241295 — SOMATOM On.site
- K241440 — HealthCCSng
- K233731 — CardIQ Suite
- K241713 — HiRise (1040-230)
- K233767 — OmniTom Elite
- K233875 — Brainomix 360 e-Lung
- K232491 — CT 5300
- K233583 — FCT iSTREAM Phase 1
- K233698 — True Enhance DL
- K232227 — ABLATE-IQ
- K232835 — Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
- K233750 — ECG-less Cardiac
- K233657 — NAEOTOM Alpha
- K233650 — SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed
- K233753 — AI-Rad Companion (Pulmonary)
- K232022 — CAS-One IR
- K233749 — Revolution Ascend Sliding
- K233080 — HealthFLD
- K234030 — Clear Guide SCENERGY
- K232412 — LungQ v3.0.0
- K232136 — syngo.CT Applications
- K232206 — SOMATOM Pro.Pulse
- K233334 — Aquilion Serve SP (TSX-307B/1) V1.3
- K232155 — syngo.CT Dual Energy
- K231482 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis
- K231631 — BriefCase-Quantification
- K232392 — CT Lung Ventilation Analysis Software (CT:V)
- K232045 — MeVis Liver Suite
- K230370 — SpotLight/SpotLight Duo (with DLIR option)
- K231574 — Scenaria View 4.2
- K230220 — NeuViz 128 Multi-Slice CT Scanner System
- K230130 — Micromate Navi+
- K231281 — Aquilion Serve (TSX-307A/1) V1.3
- K230162 — uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
- K223261 — Open Rib
- K223424 — Spine Auto Views
- K230421 — SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash
- K230112 — CAC Software
- K223447 — OmniTom Elite
- K223758 — Epione
- K230223 — iCAC Device
- K230807 — Deep Learning Image Reconstruction
- K222360 — AI-Rad Companion (Cardiovascular)
- K223514 — Spectral Bone Marrow
- K223726 — Aquilion Precision (TSX-304A/4) V10.14 with AiCE
- K222819 — Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
- K223028 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
- K223804 — PercuNav Image Fusion and Interventional Navigation System
- K223311 — Philips CT 3500
- K213465 — CardioGraphe
- K222361 — AI-Rad Companion (Musculoskeletal)
- K213759 — XACT Robotic System, ACE Model
- K220986 — Aquilion Precision (TSX-304A/4) V10.10 with AiCE
- K213713 — AI-Rad Companion (Pulmonary)
Data sourced from openFDA. This site is unofficial and independent of the FDA.