EFAI NeuroSuite CT ICH Assessment System
K-Number: K231025 · 2023-10-04
ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2023-10-04
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EFAI NeuroSuite CT ICH Assessment System is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2023-10-04 under approval number K231025. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EFAI NeuroSuite CT ICH Assessment System?
EFAI NeuroSuite CT ICH Assessment System is a medical device that received FDA 510(k) clearance on 2023-10-04. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K231025.
When was EFAI NeuroSuite CT ICH Assessment System approved by the FDA?
EFAI NeuroSuite CT ICH Assessment System received FDA 510(k) clearance on 2023-10-04, under approval number K231025.
What company makes EFAI NeuroSuite CT ICH Assessment System?
EFAI NeuroSuite CT ICH Assessment System is manufactured by Ever Fortune.Ai, Co., Ltd..
What is the FDA product code for EFAI NeuroSuite CT ICH Assessment System?
The FDA product code for EFAI NeuroSuite CT ICH Assessment System is QAS.
Related Clinical Trials
NCT05016219
Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
RECRUITING
NCT05855135
Assessment of Combined CCM and ICD Device in HFrEF
ACTIVE_NOT_RECRUITING
NCT02234128
Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility
COMPLETED
NCT07173309
Evaluation of Eye Gaze Sharing in the Operating Room
RECRUITING
NCT07603531
Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema
NOT_YET_RECRUITING
NCT07174479
Eye Gaze Guidance Evaluation in Phantoms
COMPLETED
Related PubMed Literature
PMID: 42168293
Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling.
Scientific reports (2026)
PMID: 41887630
Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa.
BMJ open (2026)
PMID: 41054198
Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences.
International journal of technology assessment in health care (2025)
PMID: 40866856
Prognostic value of nutritional risk assessment indices in patients with digestive system tumors.
BMC cancer (2025)
Other Devices by Ever Fortune.Ai, Co., Ltd.
K211257EFAI PACS Picture Archiving and Communication System
K221552EFAI ChestSuite XR Pneumothorax Assessment System
K222076EFAI ChestSuite XR Pleural Effusion Assessment System
K213731EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
K220264EFAI RTSuite CT HN-Segmentation System
K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Related Devices (Code: QAS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.