510(k) clearances

Heuron ICH

Heuron Co., Ltd. · Radiology

K233247Substantially EquivalentTraditionalQAS
Open FDA's page for this record
Third party flag
N
City
Seoul
Advisory committee description
Radiology
Address 1
10f, C, 150, Yeongdeungpo-Ro, Yeongdeungpo-Gu
Statement or summary
Summary
Product code
QAS
Zip code
07292
Applicant
Heuron Co., Ltd.
Decision date
2024-05-15
Decision code
SESE
Country code
KR
Device name
Heuron ICH
Advisory committee
RA
Contact
Inah Jeong
K number
K233247
Date received
2023-09-28
Review advisory committee
RA
Postal code
07292
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Radiological Computer-Assisted Triage And Notification Software
Medical specialty description
Radiology
Regulation number
892.2080
Device class
2
Registration number
3021915828, 3021032044, 3017604664, 3014938447, 3017840913, 3014665798, 3015763655, 3016727312, 3011205675, 3035495311, 3017210169, 3007301305, 3023702863, 3012453401, 3034656245, 3014678441, 3017489096, 3004977335, 3038177848
FEI number
3021915828, 3021032044, 3017604664, 3014938447, 3017840913, 3014665798, 3015763655, 3016727312, 3035495311, 3017210169, 3007301305, 3023702863, 3012453401, 3034656245, 3014678441, 3017489096, 3004977335, 3014269683, 3038177848
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.