Atlas FDA

Radiology

14,649 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
SIS System (K230977)Surgical Information Sciences, Inc.2023-05-02
CP620G LCD monitor, CP620 LCD monitor (K230643)Nanjing Jusha Display Technology Co., Ltd.2023-05-01
CarnaLife Holo (K221870)Medapp S.A.2023-05-01
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (K230600)Spectrum Dynamics Medical, Ltd.2023-04-28
Nanox.ARC (K222934)Nano-X Imaging , Ltd.2023-04-28
Ingenia Elition and MR 7700 MR Systems (K230972)Philips Medical Systems Nederland B.V.2023-04-28
32HL512D, 31HN713D, 32HQ713D (K230845)Lg Electronics.Inc2023-04-27
Precision DL (K223212)GE Healthcare2023-04-27
MR DWI/FLAIR Measurement V1.0 (K230552)Olea Medical2023-04-26
Ceevra Reveal 3 (K222676)Ceevra, Inc.2023-04-25
Konicaminolta DI-X1 (K230906)Konica Minolta, Inc.2023-04-25
iCAC Device (K230223)Bunkerhill, Inc.2023-04-25
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) (K230140)Compai Healthcare (Suzhou) Co.,Ltd2023-04-24
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) (K230136)Compai Healthcare (Suzhou) Co.,Ltd2023-04-24
EzDent Web (K230468)Ewoosoft Co., Ltd.2023-04-21
ViewFinder Software Version 1.1 (K223501)Elaitra, Ltd.2023-04-21
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System (K230084)Samsung Medison Co., Ltd.2023-04-21
Velacur (K223287)Sonic Incytes2023-04-20
Deep Learning Image Reconstruction (K230807)Ge Healthcare Japan Corporation2023-04-20
RadiForce RX270 (K223768)Eizo Corporation2023-04-20
ART-Plan (K230023)Therapanacea Sas2023-04-19
Quantib Prostate (K230772)Quantib B.V.2023-04-17
X-CUBE 50, X-CUBE 60 (K223564)Alpinion Medical Systems Co., Ltd.2023-04-17
AutoContour Model RADAC V3 (K230685)Radformation, Inc.2023-04-14
Ezra Flash (K230264)Ezra Ai, Inc.2023-04-13
UniCam Evo Software (K230393)Inter Medical Medizintechnik GmbH2023-04-13
CerebralGo Plus (K213986)Yukun (Beijing) Technology Co., Ltd.2023-04-13
Augmento (K222781)Deeptek Medical Imaging Private Limited2023-04-11
RCT800 (K230753)Ray Co., Ltd.2023-04-11
Ultrasound System 2300 (K223830)Bk Medical Aps2023-04-11
DMX (K223550)Del Medical, Inc.2023-04-10
ARIA Radiation Therapy Management (v18.0) (K230699)Varian Medical Systems, Inc.2023-04-10
Limbus Contour (K230575)Limbus Ai, Inc.2023-04-07
Dental CT Scanner AXR (K223816)Alliage S/A Industrias Medico Odontológica2023-04-07
AI-Rad Companion (Cardiovascular) (K222360)Siemens Medical Solutions U.S.A.2023-04-06
Contour ProtégéAI (K223774)Mim Software, Inc.2023-04-06
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems (K223458)Philips Medical Systems Nederland B.V.2023-04-06
Annalise Enterprise CTB Triage Trauma (K223240)Annalise-Ai Pty , Ltd.2023-04-03
SonoAir Series Digital Color Doppler Ultrasound System (K223570)CHISON Medical Technologies Co., Ltd.2023-03-31
RadAlly (K213660)Imaging Wave, LLC2023-03-31
Iris AirShuttle™ (K230312)Qfix2023-03-31
Formus Hip (K213272)Formus Labs, Ltd.2023-03-31
Butterfly iQ/iQ+ Ultrasound System (K220068)Butterfly Network, Inc.2023-03-31
CereFlow™ V1.2 (K211059)Translational Mri, LLC2023-03-31
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (K223017)Canon Medical Systems Corporation2023-03-31
Comfort Marker 2.0 (K222112)Medical Precision BV2023-03-30
Emory Cardiac Toolbox 4.3 (K223422)Syntermed2023-03-30
InterView XP; InterView FUSION (K221984)Mediso Medical Imaging Systems, Lttd.2023-03-29
RayStation 12A (K222312)RaySearch Laboratories AB (PUBL)2023-03-29
MAGNETOM Amira; MAGNETOM Sempra (K223343)Siemens Medical Solutions USA, Inc.2023-03-28
Annalise Enterprise CXR Triage Trauma (K222179)Annalise-Ai Pty , Ltd.2023-03-28
Annalise Enterprise CXR Triage Trauma (K222268)Annalise-Ai Pty , Ltd.2023-03-28
RadioLens v1.0 (K222174)Synapsica2023-03-28
DTX Studio Clinic 3.0 (K221921)Nobel Biocare AB2023-03-28
Overjet Caries Assist (K222746)Overjet, Inc.2023-03-27
MPXA-2000 (K222036)Medipixel, Inc.2023-03-22
Syngo Carbon Space VA30A (K230561)Siemens Healthcare GmbH2023-03-21
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) (K230520)Barco N.V.2023-03-21
FlightPlan for Embolization (K223490)GE Medical Systems SCS2023-03-21
MOBINEURO Alita Intraoperative MRI System (K223875)Sino Canada Health Engineering Research Institute (Hefei)2023-03-20
P-Cure Proton Beam Therapy System (K221996)P-Cure, Ltd.2023-03-20
Viz AAA (K223443)Viz. Ai, Inc.2023-03-17
RT Elements (4.0) (K223279)Brainlab AG2023-03-14
Aarhus Applicator Set (K222775)Varian Medical Systems, Inc.2023-03-13
uMI Panorama (K223325)Shanghai United Imaging Healthcare Co., Ltd.2023-03-10
Spectral Bone Marrow (K223514)Ge Medical Systems, LLC2023-03-09
AccuContour (K221706)Manteia Technologies Co., Ltd.2023-03-09
Aquilion Precision (TSX-304A/4) V10.14 with AiCE (K223726)Canon Medical Systems Corporation2023-03-07
A1417MCW/A1717MCW/F1417MCW (K223930)H&abyz Co., Ltd.2023-03-06
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (K222819)Canon Medical Systems Corporation2023-03-03
CoverScan (CoverScan v1.1) (K230294)Perspectum2023-03-03
FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) (K223902)Echosens2023-03-02
BoneView (K222176)Gleamer2023-03-02
AccuFFRangio Plus (K230303)ArteryFlow Technology Co., Ltd.2023-03-02
1.5T 24E Posterior Array (K223203)Shenzhen RF Tech Co., Ltd.2023-03-02
Rapid NCCT Stroke (K222884)Ischemaview, Inc.2023-03-02
Advantis Platform (K222975)Advantis Medical Imaging Single Member P.C.2023-03-01
Xeleris V Processing and Review System (K221680)GE Healthcare2023-03-01
32HQ713D (K223423)Lg Electronics.Inc2023-03-01
EXPLORER AIR® II (K222240)Surgvision GmbH2023-02-28
AccuICAS (K221711)ArteryFlow Technology Co., Ltd.2023-02-28
SpectraWAVE Imaging System (K221257)Spectrawave, Inc.2023-02-28
AVIEW Lung Nodule CAD (K221592)Coreline Soft Co., Ltd.2023-02-24
RealNow (K213891)Yiwei Medical Technology Co., Ltd.2023-02-24
Clarus Viewer (K222757)Clarus Viewer Corporation2023-02-24
MAGNETOM Vida (K213805)Siemens Medical Solutions USA, Inc.2023-02-24
Caption Interpretation Automated Ejection Fraction Software (DEN220063)Caption Health, Inc.2023-02-24
Elekta Unity (K223209)Elekta Solutions AB2023-02-23
Brainomix 360 e-ASPECTS (K221564)Brainomix Limited2023-02-23
Jumong General (K230241)Sg Healthcare Co, Ltd.2023-02-23
MOSAIQ® OIS (Oncology Information System) (K223229)Elekta Solutions AB2023-02-23
Monaco RTP System (K223233)Elekta Solutions AB2023-02-23
3D-RD-S (K212587)Radiopharmaceutical Imaging and Dosimetry, LLC2023-02-22
Swoop® Portable MR Imaging System™ (K230208)Hyperfine, Inc.2023-02-22
BoneMRI v1.6 (K230197)Mriguidance B.V.2023-02-22
NEONA 1.5T MRI System (K222259)Time Medical Limited2023-02-21
DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip (K222977)Macromedics BV2023-02-17
EzDent-i / E2 / Prora View/ Smart M Viewer (K223820)Ewoosoft Co., Ltd.2023-02-17
Vivid S60N, Vivid S70N (K223832)Ge Medical System Ultrasound and Primary Care Diagnostics2023-02-16
uMR 680 (K222755)Shanghai United Imaging Intelligence Co., Ltd.2023-02-16
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