Ultrasound System SONIMAGE HS2

GUDID 04560141949355

KONICA MINOLTA, INC.

General-purpose ultrasound imaging system
Primary Device ID04560141949355
NIH Device Record Keye7e1c1ba-79b7-45ce-8d01-c4228fbdc9a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasound System SONIMAGE HS2
Version Model NumberADDW
Company DUNS692076161
Company NameKONICA MINOLTA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104560141949355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-14
Device Publish Date2020-04-06

On-Brand Devices [Ultrasound System SONIMAGE HS2]

04560141949355ADDW
04560141949348ADDV

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