PeekMed web

Primary DI
05600120304818
Brand
PeekMed web
Company
PEEK HEALTH, S.A.
Model
v1
Device description
PeekMed web is a system that allows healthcare professionals to plan a surgery procedure simulating 2Dand 3D environments. In the case of a 3D environment, the healthcare professional can resort to a 3Dmodel generated from a previous imaging study on the patient and 3D digital representations of the implantmaterial to be used during surgery, e.g. screws, fixation plates, or full prosthesis, deriving from severalproducing companies.The software imports diagnostic imaging studies (e.g. X-rays or Computed Tomography (CT)) from a storage(e.g., CD Rom, local folder). In parallel, there is a database containing digital representations of prostheticmaterials (templates) supplied by their respective manufacturers, which offers the possibility of insertingtemplates during the surgery planning. As PeekMed web is capable of representing the medical images ina 2D and/or 3D environment, performing relevant measurements on those images and also capable ofadding templates, it then can perform a total overview of the surgery.Being software it does not interact with any part of the body of the user and/or patient.
Published
2025-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K240926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240926000PeekMed webPeek Health, S.A.2024-12-06LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05600120304818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05600120304818056001203048185600120304818

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
338110102
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05600120304801PeekMedv22025-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
00889024707092OrthoGrid®Orthogrid Systems, Inc.QIH2026-07-15
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953113493LOGIQGE Ultrasound Korea Ltd.QIH2026-01-21
00198953042731LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042755LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042762LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042779LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042793LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10