FDA.reportPublic FDA data

ADAS 3D

Primary DI
08437021722093
Brand
ADAS 3D
Company
ADAS3D MEDICAL S.L.
Model
2.13
Published
2026-05-12
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
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240791000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240791000ADAS 3DAdas3D Medical S.L.2024-09-09QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437021722093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437021722093084370217220938437021722093

GMDN Terms#

Term, Definition table
TermDefinition
Surgical simulation systemA mobile computerized assembly of mains electricity (AC-powered) devices intended to collect and manipulate medical imaging [e.g., computed tomography (CT), magnetic resonance imaging (MRI)] data to create a patient-specific, virtual, three-dimensional (3-D), interactive model to enable a surgeon to simulate, rehearse, and plan a surgical procedure (e.g., cranial) prior to surgery. It includes dedicated software, and dedicated and/or off-the-shelf hardware such as a cart, a personal computer (PC), monitors, 3-D glasses, and a controller to simulate surgical devices and perform measurements. It is capable of collecting patient demographics, which may be anonymised.

Regulatory Flags#

DUNS number
469095791
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437021722086ADAS 3DV.2.122023-06-14
08437021722055ADAS 3Dv2.92022-03-09
08437021722024ADAS 3DV2.102021-10-14
08437021722031ADAS 3DV2.82021-10-14
08437021722048ADAS 3DV2.62021-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
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
00754016387111ANDIImeka Solutions IncQIH2023-09-01
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