FDA.reportPublic FDA data

MEDIUM TORSO SIMULATOR

Primary DI
00814848020232
Brand
MEDIUM TORSO SIMULATOR
Company
QUALITY ELECTRODYNAMICS LLC
Model
2001001
Catalog number
MAC000112
Published
2017-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814848020232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814848020232008148480202328148480202320814848020232

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy simulation systemAn assembly of diagnostic and radiation therapy devices comprising a radiation therapy simulation system intended for radiation therapy treatment planning applications. It is configured as a diagnostic x-ray system, e.g., fluoroscopic, planar, computed tomography (CT) with associated hardware and software. It is used to localize the field volume to be exposed during radiation therapy and to confirm the position and size of the therapeutic irradiation field produced by a specific set of treatment parameters that have been developed. A radiation therapy treatment planning system (RTTPS) will typically interface to receive the parameters being measured for further use in treatment calculations.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614760119
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814848020836Contour Hand Wrist 0.55TQ70002322026-04-23
0081484802081216ch Flex SPEEDER Medium 1.5TQ70002462025-05-20
0081484802082916ch Flex SPEEDER Large 1.5TQ70002472025-05-20
00814848020775SureWave ElastographyQ70002252025-04-12
00814848020799Contour ShoulderQ70002222025-04-03
0081484802078216ch T/R Hand Wrist CoilQ70002382024-07-18
00814848020751Contour KneeQ70001872023-01-19
008148480205152Tx 28Rx Knee CoilQ70001882021-02-12
0081484802024916ch T/R Hand Wrist CoilQ70001802018-01-30
00814848020256Contour 24Q70001842018-06-04
00814848020508Shape CoilQ70001992021-08-20
00814848020546Shape CoilQ70001982021-08-20
00814848020423Contour 24Q70001832019-03-21
0081484802000318ch T/R Knee CoilQ70000742016-09-16
00814848020010Atlas SPEEDER Head/Neck CoilQ70001462016-09-16
00814848020027Wrist SPEEDER CoilQ70000052016-09-16
00814848020034Tx/Rx Extra Large Knee CoilQ70000062016-09-16
00814848020041TxRx 15ch Knee CoilQ70000082016-09-16
00814848020065TxRx 15ch Knee CoilQ70000162016-09-16
00814848020089Shoulder SPEEDER CoilQ70000182016-09-16

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Primary DI, Brand, Company table
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