Atlas FDA

Radiology

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

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RecordFirmDate
OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T (K211658)Noras Mri Products GmbH2022-03-03
nordicDSC (K212720)Nordicneurolab AS2022-03-03
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei (K213516)Philips Medical Systems Nederland B.V.2022-03-03
MR Elastography; MZEK-001A (K220018)Canon Medical Systems Corporation2022-03-03
NovaGuide 2 Intelligent Ultrasound (K213279)Novasignal Corporation2022-03-02
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph (K213579)Fona S.R.L2022-03-02
BoneView (K212365)Gleamer2022-03-01
Digimamo D (K210151)Vmi Tecnologias Ltda2022-03-01
Explorer Air II (K214097)Surgvision GmbH2022-02-25
OmniTom Elite (K211711)Neurologica Corporation, A Subsidiary of Samsung Electronics2022-02-25
MAGNETOM Vida with syngo MR XA50A (K213693)Siemens Medical Solutions USA, Inc.2022-02-25
Epione (K211645)Quantum Surgical Sas2022-02-24
Annalise Enterprise CXR Triage Pneumothorax (K213941)Annalise-Ai2022-02-24
EzOrtho v1.3 (K220003)Ewoosoft Co., Ltd.2022-02-23
Pocket Ultrasound System (K211746)Guangdong Youkey Medical Co., Ltd.2022-02-18
Deep Learning Image Reconstruction (K213999)Ge Medical Systems, LLC2022-02-18
ExamVue Duo (K213057)Jpi Healthcare Co, Ltd.2022-02-18
Viz ANEURYSM, Viz ANX (K213319)Viz. Ai, Inc.2022-02-18
Multitom Rax with True2scale Body Scan Option (K212212)Siemens Medical Solutions2022-02-18
Voluson P6, Voluson P8 (K213689)GE Healthcare2022-02-17
14HQ901G-B (K214044)Lg Electronics.Inc2022-02-16
ArtUs (K211248)Telemed2022-02-11
ACUSON P500 Ultrasound System (K213487)Siemens Medical Solutions USA, Inc.2022-02-11
EzRay M18 (Model: VMX-P400) (K213462)VATECH Co., Ltd.2022-02-11
SIGNA Artist Evo (K213603)Ge Healthcare (Tianjin) Company Limited2022-02-11
Rapid (K213165)Ischemaview, Inc.2022-02-08
Veuron-Brain-pAb2 (K213801)Heuron Co., Ltd.2022-02-04
Revolution Ascend (K213938)Ge Healthcare Japan Corporation2022-02-04
Magnifico Open, Magnifico MSK (K212419)Esaote, S.p.A.2022-02-04
Radialis PET Camera (K214062)Radialis, Inc.2022-02-04
Micro C Medical Imaging System, M01 (K212654)Oxos Medical, Inc.2022-02-04
smart-sync (K212271)Northh Medical GmbH2022-02-04
Digital Radiography CXDI-Pro, Digital Radiography D1 (K220098)Canon, Inc.2022-02-04
Contour ProtégéAI (K213976)Mim Software, Inc.2022-02-03
SKR 3000 (K213908)Konica Minolta, Inc.2022-01-31
syngo.CT Brain Hemorrhage (K203260)Siemens Medical Solutions USA, Inc.2022-01-28
X-CUBE i8, X-CUBE i9 (K213523)Alpinion Medical Systems Co., Ltd.2022-01-28
Sim&Size (K212373)Sim&Cure2022-01-27
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 (K212333)Canon Medical Systems Corporation2022-01-24
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 (K213780)Canon, Inc.2022-01-24
Universal DR 1748 (K214030)Konica Minolta Healthcare Americas, Inc.2022-01-21
SIGNA PET/MR (K213709)Ge Medical Systems, LLC2022-01-20
SIGNA Hero (K213668)Ge Healthcare (Ge Medical Systems, LLC)2022-01-20
syngo.CT Extended Functionality (K214019)Siemens Medical Solutions USA, Inc.2022-01-20
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K214084)Cefla S.C.2022-01-20
3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory (K213438)Adaptiiv2022-01-19
Caption Interpretation Automated Ejection Fraction Software (K210747)Caption Health2022-01-19
Follicle Clarity (K212012)Cycle Clarity2022-01-19
SIGNA Prime (K211980)Ge Healthcare (Tianjin) Company Limited2022-01-16
Respiratory Gating for Scanners v2.0 (K213927)Varian Medical Systems, Inc.2022-01-14
Quantib ND (K213737)Quantib B.V.2022-01-14
Eclipse II with Smart Noise Cancellation (K213307)Carestream Health, Inc.2022-01-14
Precise Image (K210760)Philips Medical Systems Nederland B.V.2022-01-14
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert (K213642)GE Healthcare2022-01-13
Straight Arm DDR (K214012)Konica Minolta Healthcare Americas, Inc.2022-01-12
UNiD Spine Analyzer (K212005)Medicrea International, Inc.2022-01-12
Esteya (K213942)Nucletron B.V.2022-01-11
ES1 System (K213102)E-Scopics2022-01-11
AIBOLIT 3D+ (K211443)Aibolit Technologies, LLC2022-01-07
Gold Anchor (K213053)Naslund Medical AB2022-01-06
TOMTEC-ARENA (K213544)Tomtec Imaging Systems GmbH2022-01-06
VUZE System (K210830)Vuze Medical , Ltd.2022-01-03
eco-x Series (eco-x, eco-x-s) (K211159)Hdx Will Corp.2021-12-30
LiverSmart (K213776)Resonance Health Analysis Services Pty, Ltd.2021-12-29
CONVIVO In Vivo Pathology Suite (K211156)Carl Zeiss Meditec, AG2021-12-29
Sonosite PX Ultrasound System (K213763)FUJIFILM Sonosite, Inc.2021-12-27
D²RS and D²RS 9090 (K213479)Stephanix2021-12-23
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T (K213766)Invivo Corporation2021-12-23
Solas OR (K213691)Cirdan Imaging, Ltd.2021-12-22
Ultrast Gel (K211691)Ultrast, Inc.2021-12-22
BoneMRI (K202404)Mriguidance B.V.2021-12-22
Claritas iPET (K213140)Claritas Healthtech Pte, Ltd.2021-12-22
iSR’obot Mona Lisa 2.0 (K213411)Biobot Surgical Pte., Ltd.2021-12-22
BU-CAD (K210670)Taihao Medical, Inc.2021-12-21
qXR-BT (K212690)Qure.Ai Technologies2021-12-21
EchoGo Core (2.0) (K213275)Ultromics Limited2021-12-20
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition (K213715)Ge Medical Systems, LLC2021-12-17
InkSpace Imaging Pediatric Body Array (K213397)Inkspace Imaging, Inc.2021-12-17
Libby IAAA v1.0 (K210931)Dyad Medical, Inc.2021-12-17
VBrain (K213628)Vysioneer, Inc.2021-12-16
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio (K212420)Brainlab AG2021-12-16
Koios DS (K212616)Koios Medical, Inc.2021-12-16
6MP Color LCD Monitor CL-S600 (K212985)Jvckenwood Corporation2021-12-16
BIT-Motion (K211039)Dde Mri Solutions, Ltd.2021-12-15
Will3D (K211114)Hdx Will Corp.2021-12-15
HealthPPT (K211803)Zebra Medical Vision, Ltd.2021-12-15
RT-Mind-AI (K213155)Medmind Technology Co., Ltd.2021-12-15
Helianthus (K202822)Metaltronica Spa2021-12-15
MRIdian Linac System (K212958)Viewray, Incorporated2021-12-14
MULTIX Impact, MULTIX Impact C (K213700)Siemens Medical Solutions USA, Inc.2021-12-13
Philips Radiology Smart Assistant (K212186)Philips Medical Systems Dmc GmbH2021-12-13
Nyquist.IQ (K212890)Omega Medical Imaging, LLC2021-12-13
EXA (K203743)Konica Minolta Healthcare Americas, Inc.2021-12-10
X-Clever (K212137)Lg Electronics.Inc2021-12-10
Comfort Marker 2.0. (DEN200041)Medical Precision BV2021-12-10
LVivo Seamless (K212466)Dia Imaging Analysis, Ltd.2021-12-09
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 (K213303)Infraredx, Inc.2021-12-07
Al-Rad Companion (Pulmonary) (K213096)Siemens Medical Solutions USA, Inc.2021-12-06
21HQ513D (K212295)Lg Electronics.Inc2021-12-03
Cydar EV (Series B) and Cydar EV Maps (K212442)Cydar , Ltd.2021-12-03
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