ERGO++

GUDID 00858164002206

ELEKTA, INC.

Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software
Primary Device ID00858164002206
NIH Device Record Key549083fd-f5c9-4576-9ec7-312ae2043d56
Commercial Distribution StatusIn Commercial Distribution
Brand NameERGO++
Version Model NumberERGO++
Company DUNS079089435
Company NameELEKTA, INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858164002206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUJSystem,Planning,Radiation Therapy Treatment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-08-05
Device Publish Date2017-11-10

Devices Manufactured by ELEKTA, INC.

00858164002381 - Aqua2023-06-30
00858164002367 - MOSAIQ2021-12-10
00858164002336 - MOSAIQ2019-11-08
00858164002275 - Monaco2019-10-25
00858164002237 - MOSAIQ2019-08-12
00858164002251 - MOSAIQ2019-08-12
00858164002039 - Atlas-Based Autosegmentation2019-08-05
00858164002114 - XiO2019-08-05

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