FDA.reportPublic FDA data

Contour Knee

Primary DI
00814848020751
Brand
Contour Knee
Company
QUALITY ELECTRODYNAMICS LLC
Model
Q7000187
Published
2023-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223429000Contour KneeQuality Electrodynamics, LLC2023-01-13MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814848020751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814848020751008148480207518148480207510814848020751

GMDN Terms#

Term, Definition table
TermDefinition
MRI system coil, radio-frequencyA radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.

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
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
00814848020096TxRx CP Extremity CoilQ70000192016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278925282NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDMOS2026-05-11
00814848020836Contour Hand Wrist 0.55TQUALITY ELECTRODYNAMICS LLCMOS2026-04-23
00850083516000Nuzzle Body Array, 1.5TInkspace Imaging, Inc.MOS2026-04-21
00850083516017Silhouette Body Array – PH 3T (Cherry Blossoms)Inkspace Imaging, Inc.MOS2026-04-21
00860008041371Snuggle Pediatric Array – PH 3T (Dino)Inkspace Imaging, Inc.MOS2026-04-21
00860008041395Nuzzle Body Array – PH 3T (Whimsical)Inkspace Imaging, Inc.MOS2026-04-21
00884838130548DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130555DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130562DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130579DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130586DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130593DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130609DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130616DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130623DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132597DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132603DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838093089MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838093096MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838093102MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098190MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098367MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098510MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838108073MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838118997MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-10-01
00884838119000MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-10-01
00884838108080MRI CoilsPhilips Ds North America LLCMOS2025-09-30
00884838111172DUNLEEPhilips Medical Systems Nederland B.V.MOS2025-09-30
00884838111189DunleePhilips Medical Systems Nederland B.V.MOS2025-09-30
00884838118980MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-09-30