Ultrasound System SONIMAGE HS1

GUDID 04560141947436

KONICA MINOLTA, INC.

General-purpose ultrasound imaging system
Primary Device ID04560141947436
NIH Device Record Keydf4ad6ee-5479-458b-9703-9b70f29eb4e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasound System SONIMAGE HS1
Version Model NumberAC7H
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
GS104560141947436 [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 Date2018-12-31
Device Publish Date2018-11-28

On-Brand Devices [Ultrasound System SONIMAGE HS1]

04560141947436AC7H
04560141947429AC7J
04560141947412AC7G
04560141946385AAEU
04560141945470A9RR
04560141945463A9RP
04560141944534A8WA
04560141941588A8AR
04560141940031A7AP

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