510(k) clearances

Ultrasound Workspace (UWS 6.0)

Philips Ultrasound, LLC · Radiology

K241659Substantially EquivalentTraditionalQIH
Open FDA's page for this record
Third party flag
N
City
Bothell
Advisory committee description
Radiology
Address 1
22100 Bothell Everett Hwy.
Statement or summary
Summary
Product code
QIH
Zip code
98021
Applicant
Philips Ultrasound, LLC
Decision date
2025-02-10
Decision code
SESE
Country code
US
Device name
Ultrasound Workspace (UWS 6.0)
Advisory committee
RA
Contact
Petra Galgoczy
K number
K241659
State
WA
Date received
2024-06-10
Review advisory committee
RA
Postal code
98021
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Automated Radiological Image Processing Software
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
3036502204, 3005403518, 1000432246, 9710090, 3018094310, 3028006458, 3008729547, 3006165260, 3025602618, 3017976149, 3015169361, 3017058304, 3010703925, 3008837339, 3003768277, 3018064242, 3044776706, 3015612252, 3010656400, 3019541896, 9680269, 3042248552, 3003899230, 3014310698, 3018302800, 1644408, 3025110425, 3030088963, 3031915908, 3023217364, 3010398867, 3011063460, 3016965352, 3002808157, 3004141078, 3016585383, 3020703662, 3006209933, 3019878658, 3008284470 +201 more
FEI number
3036502204, 3005403518, 1000432246, 3018094310, 3028006458, 3003405980, 3003310366, 3008729547, 3006165260, 3025602618, 3017976149, 3015169361, 3017058304, 3003309342, 3008837339, 3010703925, 3018064242, 3044776706, 3015612252, 3003408255, 3019541896, 3010656400, 3003899230, 3042248552, 3014310698, 3018302800, 3025110425, 3030088963, 3031915908, 3023217364, 3010398867, 3011063460, 3003377038, 3016965352, 3002808157, 3016585383, 3004141078, 3002808529, 3002808382, 3020703662 +201 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.

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.