Aidoc medical Ltd.
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
Aidoc Always On Healthcare AI
7605 解决方案 解决方案 探索 Aidoc 的临床 AI 解决方案如何提高医院效率、显示经过验证的投资回报并帮助实现更好的结果。了解更多 → 放射学 在简化的工作流程中优先考虑结果并激活护理团队 在单一平台上运行的 FDA 批准的最大算法组合 战略合作伙伴解决方案 心脏病学 持续测量疾病并捕获偶然发现 冠状动脉疾病 超声心动图 神经血管 通过实时通知设定神经护理标准 中风 脑动脉瘤 脊柱解决方案 血管 简化工作流程并集中患者管理 VTE 解决方案 主动脉解决方案
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Tel Aviv, Israel
- Website
- https://aidoc.com
- Categories
- 医疗保健用品
- Markets
- 以色列
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 3 official records from 3 official sources are on file. 4 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Business email on the company's own domain (record type: corporate-mail-on-domain) [our own observation, not an official record; status green] Shows the domain runs its own email rather than a free mailbox. It describes the domain, not who owns it. checked 2026-08-22. Mail server of the company domain
- Website domain registered (record type: domain-registered) [our own observation, not an official record; status green] Shows how long this web address has been registered. That is the age of the domain, not of the company: a domain can change owners. checked 2026-08-22. Domain registry record
- Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-08-22. FDA
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-22. OpenSanctions
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-22. OpenSanctions
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 8 medical devices: BriefCase-Triage (K261317, 2026), BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device (K253578, 2026), BriefCase (K213886, 2022) +5. The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-03. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)