Mano4343A Wireless Digital Flat Panel Detector

GUDID 06970569090955

Mano4336A clearance depends on Mars1717X by LTF

iRay Group

Indirect flat panel x-ray detector
Primary Device ID06970569090955
NIH Device Record Key18ed66e2-6713-4b5f-a4f0-e0601d1605ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameMano4343A Wireless Digital Flat Panel Detector
Version Model NumberMano4343A
Company DUNS421363780
Company NameiRay Group
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970569090955 [Primary]

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-21
Device Publish Date2025-05-13

Devices Manufactured by iRay Group

06970569090993 - iRay2026-01-21 The iScan system is an intraoral scanner that uses the optical scanning method to obtain the three-dimensional shape feature dat
06970569090856 - Digital Intraoral X-ray Imaging System2025-09-08 The Digital Intra-Oral X-Ray Imaging System is used in conjunction with dental Radiography in medical units. The product is used
06970569090863 - Digital Intraoral X-ray Imaging System2025-09-08 The Digital Intra-Oral X-Ray Imaging System is used in conjunction with dental Radiography in medical units. The product is used
06970569091006 - Digital Radiographic Imaging Acquisition Software - DR (RiasDR)2025-09-03 Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
06970569091020 - Wireless Digital Flat Panel Detector2025-06-19 DR10FW Wireless Digital Flat Panel Detector_LTF
06970569090931 - Mano4336A Wireless Digital Flat Panel Detector2025-05-21 Mano4336A clearance depends on Mars1417X by LTF
06970569090948 - Mano4336F Wireless Digital Flat Panel Detector2025-05-21 Mano4336F clearance depends on Mars1417X by LTF
06970569090955 - Mano4343A Wireless Digital Flat Panel Detector2025-05-21Mano4336A clearance depends on Mars1717X by LTF
06970569090955 - Mano4343A Wireless Digital Flat Panel Detector2025-05-21 Mano4336A clearance depends on Mars1717X by LTF

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