FDA.reportPublic FDA data

Simplicit90Y

Primary DI
B334SY2P160
Brand
Simplicit90Y
Company
MIRADA MEDICAL LIMITED
Model
2.16
Published
2025-02-10
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
B334SY2P160PrimaryHIBCC0

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B334RTX1P100RTx1.102024-10-29
B334SY2P120Simplicit90Y2.122024-02-26
B334XD4P20XD4.22024-02-07
B334SY2P10Simplicit90Y2.102023-08-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
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00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01