510(k) clearances

NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)

Nurodata, Inc. · Radiology

K242681Substantially EquivalentTraditionalIYN
Open FDA's page for this record
Third party flag
N
City
Zhubei
Advisory committee description
Radiology
Address 1
5f.-3, #6-2, Sec.2, Shengyi Rd., Hsinchu Science Park
Statement or summary
Summary
Product code
IYN
Zip code
302058
Applicant
Nurodata, Inc.
Decision date
2025-02-20
Decision code
SESE
Country code
TW
Device name
NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)
Advisory committee
RA
Contact
Hsien-chen Chiou
K number
K242681
Date received
2024-09-06
Review advisory committee
RA
Postal code
302058
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Imaging, Pulsed Doppler, Ultrasonic
Medical specialty description
Radiology
Regulation number
892.1550
Device class
2
Registration number
1000602763, 3005403518, 3003600763, 3005406110, 3018094310, 9710090, 3003774756, 1062741, 3008487708, 3008729547, 1000513161, 2518897, 3014555455, 8010047, 3010703925, 3003589956, 3017955833, 9616774, 3009499478, 9680269, 3003899230, 3010663777, 2521877, 3010398867, 3003681187, 3005334138, 3003637092, 3011686611, 3016436764, 1054713, 2134812, 3016493665, 3010390468, 3026047529, 3003412859, 3002808148, 3009196578, 3015806723, 3011137372, 3009156722 +182 more
FEI number
1000602763, 3005403518, 3003600763, 3005406110, 3018094310, 3003774756, 3008487708, 3008729547, 1000513161, 3014555455, 3010703925, 3003309342, 3003589956, 3017955833, 3003408255, 3009499478, 3002808127, 3003899230, 1000124215, 3010663777, 2521877, 3010398867, 3003681187, 3005334138, 3003637092, 3011686611, 3002808529, 3016436764, 3002808382, 3016493665, 3010390468, 3026047529, 3003412859, 3000957797, 3002808148, 3009196578, 3015806723, 3009156722, 3027501622, 3019216 +182 more
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.