Atlas FDA

Radiology

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

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RecordFirmDate
CorInsights MRI (K193287)Adm Diagnostics, Inc.2020-11-20
Revolution Ascend (K203169)Ge Healthcare Japan Corporation2020-11-20
Vscan Air (K202035)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-11-20
HALO (K200873)Nico-Lab B.V.2020-11-20
DTX Studio Clinic (K203156)Nobel Biocare AB2020-11-20
DBSWIN, VISTAEASY (K203287)Dürr Dental SE2020-11-18
syngo.via MI Workflows, syngo MBF (K201195)Siemens Medical Solutions USA, Inc.2020-11-18
HiRise (K203187)Curvebeam, LLC2020-11-18
Venue Go (K202233)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-11-18
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) (K201382)De Gotzen S.R.L.2020-11-18
TrueView 100 Pro (K202713)Compai Healthcare (Shenzhen) Co.,Ltd2020-11-18
Genius AI Detection (K201019)Hologic, Inc.2020-11-18
PROView (K193306)GE Medical Systems SCS2020-11-17
Venue (K202132)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-11-13
SIGNA Architect (K202966)Ge Healthcare (Ge Medical Systems, LLC)2020-11-13
Apache Ultrasound System (Model C62) (K202074)Compal Electronics, Inc.2020-11-12
FastStroke, CT Perfusion 4D (K193289)GE Medical Systems SCS2020-11-12
ExacTrac Dynamic (K203173)Brainlab AG2020-11-12
Nio Fusion 12MP (MDNC-12130) (K203106)Barco N.V.2020-11-10
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System (K201990)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-11-09
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS (K203128)Olympus Medical Systems Corp.2020-11-09
Neuro.Al Algorithm (K200750)Terarecon,Inc.2020-11-06
AI-Rad Companion Organs RT (K193562)Siemens Medical Solutions USA, Inc.2020-11-06
MyHip Planner & Verifier (K200350)Medacta International S.A.2020-11-04
Arietta 65 (K202422)Hitachi Healthcare Americas2020-11-04
T-Lite (K201988)Sonoscanner2020-10-30
HS30 Diagnostic Ultrasound System (K202556)Samsung Medison Co., Ltd.2020-10-30
WRDensity by Whiterabbit.ai (K202013)Whiterabbit.Ai, Inc.2020-10-30
AutoContour (K200323)Radformation, Inc.2020-10-30
CloudVue (K203058)International Medical Solutions, Inc.2020-10-29
LSN (K201092)Imaging Biometrics, LLC2020-10-29
Dental Computed Tomography X-Ray System, Green X (K201627)VATECH Co., Ltd.2020-10-27
OrthoNext Platform System (K202519)Orthofix Srl2020-10-27
1212FCA (K202722)Rayence Co., Ltd.2020-10-26
SIR-Spheres Microspheres Activity Calculator (SMAC) (K202392)Sirtex Medical US Holdings, Inc.2020-10-23
Planmed Clarity 2D and Clarity S (K192317)Planmed OY2020-10-23
EzOrtho (K202948)Ewoosoft Co., Ltd.2020-10-22
Voluson E10 (K201768)GE Healthcare2020-10-22
OASIS MRI System (K202030)Hitachi Healthcare Americas2020-10-21
YSIO X.pree (K201670)Siemens Medical Solutions USA, Inc.2020-10-21
4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ (K202374)Shenzhen Beacon Display Technology Co., Ltd.2020-10-19
A View LCS (K201710)Coreline Soft Co., Ltd.2020-10-16
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System (K202737)Canon Medical Systems Corporation2020-10-16
SIGNA 7.0T (K201615)Ge Medical Systems, LLC2020-10-15
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System (K202683)Siemens Medical Solutions USA, Inc.2020-10-15
Cartesion Prime, PCD-1000A, V10.7 (K202349)Canon Medical Systems Corporation2020-10-15
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 (K202364)Canon Medical Systems Corporation2020-10-15
syngo.CT Neuro Perfusion (K202213)Siemens Medical Solutions USA, Inc.2020-10-11
Yushan X-Ray Flat Panel Detector with DROC (K201528)Innocare Optoelectronics Corp.2020-10-11
Quantib Prostate (K202501)Quantib B.V.2020-10-11
Voluson SWIFT, Voluson SWIFT+ (K201828)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-10-11
31HN713D (K201777)Lg Electronics.Inc2020-10-08
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 (K201972)Canon Medical Systems Corporation2020-10-08
IPS CaseDesigner (K200810)Nobel Biocare AB2020-10-08
Radiographic System Challenge X (K202293)Sedecal., Sa.2020-10-07
AcuSee AS-P1000 System (K202119)Weipeng (Suzhou) Medical Devices Co., Ltd.2020-10-07
UDE (K202292)Ebm Technologies, Inc.2020-10-05
Affirm Contrast Biopsy (K202294)Hologic, Inc.2020-10-05
LiverMultiScan (K202170)Perspectum, Ltd.2020-10-02
Cleerly Labs v2.0 (K202280)Cleerly, Inc.2020-10-02
Clear Guide SCENERGY (K201188)Clear Guide Medical2020-09-30
e-Ortho Shoulder Software (K201928)FH Industrie2020-09-30
THINQ (K192051)Corticometrics, LLC2020-09-30
DigitalDiagnost C90 (K202564)Philips Medical Systems Dmc GmbH2020-09-30
LVivo Seamless (K202546)Dia Imaging Analysis, Ltd.2020-09-29
ImageSPECTRUM (K201273)Canon, Inc.2020-09-25
Xeleris V Processing and Review Systems (K201103)GE Healthcare2020-09-25
RayStation (K200569)RaySearch Laboratories AB (PUBL)2020-09-24
GXR-Series Diagnostic X-Ray System (K202572)DRGEM Corporation2020-09-24
Vantage Orian 1.5T, MRT-1550, V6.0 (K202210)Canon Medical Systems Corporation2020-09-22
AAA Model (K200603)Philips Ultrasound, Inc.2020-09-20
CORVUS (K201350)Best Nomos2020-09-20
EchoPAC Software Only, EchoPAC Plug-In (K200852)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-09-18
SentEP (K192890)Sentiar, Inc.2020-09-18
Caption Guidance (K201992)Caption Health2020-09-18
EOSedge (K202394)Eos Imaging2020-09-16
AVA (Augmented Vascular Analysis) (K201369)See-Mode Technologies Pte, Ltd.2020-09-16
Butterfly iQ Ultrasound System (K202406)Butterfly Network, Inc.2020-09-16
PAPAYA 3D Premium & PAPAYA 3D Premium Plus (K200469)Genoray Co., Ltd.2020-09-16
Ziehm Vision RFD 3D (K202360)Ziehm Imaging GmbH2020-09-16
Collaboration Live (K201665)Philips Ultrasound, Inc.2020-09-15
Aline Ablation Intelligence (K202297)Mirada Medical, Ltd.2020-09-11
DIAMOND-5A/6A/8A (K202156)DRGEM Corporation2020-09-10
AcroDTI Visualizer (K201948)Acroviz, Inc.2020-09-09
Vivid iq (K200708)Ge Medical Systems Ultrasound And2020-09-09
3Shape Implant Studio (K202256)3Shape Medical A/S2020-09-09
Vivid T8, Vivid T9 (K200851)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-09-09
Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit (K202014)Siemens Medical Solutions USA, Inc.2020-09-08
SIGNA Artist (K202238)Ge Healthcare (Tianjin) Company Limited2020-09-04
Ambra ProViewer (K202335)Dicom Grid Inc Dba Ambra Health2020-09-04
ArtPIX DRF (K202235)Cmt Medical Technologies, Ltd.2020-09-03
Flat Panel Detector (K201591)Ka Imaging, Inc.2020-09-03
3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ (K201211)Shenzhen Beacon Display Technology Co., Ltd.2020-09-03
ApolloVue S100 Image System (K201552)Apollo Medical Optics, Ltd.2020-09-02
EPIQ Series Diagnostic Ultrasound Systems (K202216)Philips Ultrasound, Inc.2020-09-02
Patient Administration Set (K200916)Cyclomedica Australia Pty, Ltd.2020-09-01
Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System (K202160)FUJIFILM Sonosite, Inc.2020-09-01
SpaceOAR System (K202224)Boston Scientific Corporation2020-08-28
ANCORIS (K201807)Miegmbh2020-08-27
Synapse 3D Cardiac Tools (K200973)Fujifilm Corporaton2020-08-27
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