RoseM

GUDID 08800018401606

The RSM 1824C is designed for use in Digital X-ray Images of woman breast diagnosis (mammography), which intended to be used in radiographic film/screen systems in general-purpose diagnostic procedures. The system can be applied wherever traditional X-ray screen-film cassettes are currently used.

DRTECH Corporation

Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector
Primary Device ID08800018401606
NIH Device Record Key77d8be5b-942b-4539-b8b9-6adea03619fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRoseM
Version Model NumberRSM 1824C
Company DUNS689842626
Company NameDRTECH Corporation
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800018401606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUEFull Field Digital,System,X-Ray,Mammographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-07
Device Publish Date2017-08-04

On-Brand Devices [RoseM]

08800018401903The RSM 2430C is designed for use in Digital X-ray Images of woman breast diagnosis (mammography
08800018401606The RSM 1824C is designed for use in Digital X-ray Images of woman breast diagnosis (mammography

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