FDA.reportPublic FDA data

Simplicit90Y

Primary DI
B334SY2P10
Brand
Simplicit90Y
Company
MIRADA MEDICAL LIMITED
Model
2.10
Published
2023-08-23
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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182016000Simplicit90YMirada Medical, Ltd.2018-12-06LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B334SY2P10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
211100325
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B334SY2P160Simplicit90Y2.162025-02-10
B334RTX1P100RTx1.102024-10-29
B334SY2P120Simplicit90Y2.122024-02-26
B334XD4P20XD4.22024-02-07
B334XD4P00XD4.02022-05-05
B334SY2P60Simplicit90Y2.62021-08-26
B334WORKFLOWBOX2P60Workflow Box2.62021-05-04
B334WORKFLOWBOX2P40Workflow Box2.42020-11-11
B334SY2P40Simplicit90Y2.42020-12-22
B334ALINE1P00Aline Ablation Intelligence1.02020-11-30
B334DBX1P40DBx1.42020-10-08
B334WORKFLOWBOX2P20Workflow Box2.22020-04-09
B334SY2P20Simplicit90Y2.22019-10-11
B334NMX4P20XD Nuclear Medicine4.22016-11-23
B334NMX4P40XD Nuclear Medicine4.42018-05-23
B334RTX1P60RTx1.62017-03-28
B334RTX1P80RTx1.82018-03-16
B334SY2P00Simplicit90Y2.02019-02-15
B334WORKFLOWBOX2P00Workflow Box2.02018-11-20
B334XD3P60XD3.62016-10-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
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05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
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B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20