SR-130-G 910056

GUDID 00868162000241

X-Ray Generator / Tube Housing Assembly, 100kVp / 30mA

SOURCE-RAY, INC.

Diagnostic x-ray system generator, mobile
Primary Device ID00868162000241
NIH Device Record Keyf4c8e06b-8b70-434f-884a-649a9ce79e98
Commercial Distribution StatusIn Commercial Distribution
Brand NameSR-130-G
Version Model NumberSR-130-G
Catalog Number910056
Company DUNS113928654
Company NameSOURCE-RAY, 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

Customer Support Contacts

Phone631-244-8200
Emailato@sourceray.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100868162000241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZLSystem, X-Ray, Mobile

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 Date2016-09-09

Devices Manufactured by SOURCE-RAY, INC.

00867538000311 - XRS-140-15K-P2022-02-28 X-ray Source Assembly, 140V, 15 mA- Pulsed
00867538000328 - XRS-140-7.5K-P2022-02-24 X-Ray Source Assembly, 140V, 7.5mA, Pulsed
00868162000289 - RC-1152019-04-09 X-Ray Control, Remote
00867538000304 - UC-50002018-07-06 Mobile X-Ray System for General Purpose Radiography Exams Utilizing Film, Computed Radiography, or Direct Digital Flat Panels
00868162000234 - SR-115-CG2018-07-06 X-Ray Control / Generator, 100 kVp/ 15mA
00868162000241 - SR-130-G2018-07-06X-Ray Generator / Tube Housing Assembly, 100kVp / 30mA
00868162000241 - SR-130-G2018-07-06 X-Ray Generator / Tube Housing Assembly, 100kVp / 30mA
00868162000258 - SR-130-C2018-07-06 X-Ray Control, 100kVp / 30 mA
00868162000265 - SR-1260-C2018-07-06 X-Ray Control, 120 kVp / 60mA

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.