MEVION S250i MEVION S250i

GUDID 00864366000124

MEVION MEDICAL SYSTEMS, INC.

Proton therapy system
Primary Device ID00864366000124
NIH Device Record Keyf5ca1d4e-e4ec-462c-bfeb-172b0bd47675
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEVION S250i
Version Model NumberS250i
Catalog NumberMEVION S250i
Company DUNS199652145
Company NameMEVION MEDICAL SYSTEMS, 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100864366000124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LHNSystem, Radiation Therapy, Charged-Particle, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-05

Devices Manufactured by MEVION MEDICAL SYSTEMS, INC.

00864366000100 - Mevion Medical Systems2018-07-06 Proton Beam Radiation Therapy System
00864366000124 - MEVION S250i2018-07-06
00864366000124 - MEVION S250i2018-07-06
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