ProKnow DS

GUDID 07340201500057

Elekta Solutions AB

Radiological PACS software
Primary Device ID07340201500057
NIH Device Record Key90de0544-465a-4c82-972a-992b12a4f0eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameProKnow DS
Version Model Number2.0
Company DUNS353272181
Company NameElekta Solutions AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS107340201500057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-29
Device Publish Date2024-03-21

Devices Manufactured by Elekta Solutions AB

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07340201501504 - Leksell Vantage Stereotactic System2024-12-09 Leksell Vantage™ Support Arc
07340201502129 - Leksell Vantage Stereotactic System2024-12-09 LEKSELL VANTAGE CARRIER
07340201501511 - Leksell Vantage Stereotactic System2024-09-09 LEKSELL VANTAGE ARC SYSTEM
07340201501887 - Leksell Vantage Stereotactic System2024-08-22 LEKSELL VANTAGE ARC SYSTEM
07340201501337 - Leksell Vantage Stereotactic System2024-08-14 FirmFix™ 5
07340201501290 - Leksell Vantage Stereotactic System2024-08-13 FirmFix™ 3
07340201501313 - Leksell Vantage Stereotactic System2024-08-13 FirmFix™ 4

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