QP-Prostate

Primary DI
08437021468144
Brand
QP-Prostate
Company
QUIBIM SOCIEDAD LIMITADA.
Model
1.5
Device description
"Software for quantitative analysis of prostate MRI QP-Prostate® is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard ""off-the-shelf"" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of QP-Prostate®. QP-Prostate® does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data."
Published
2024-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K203582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203582000QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.2021-02-04LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437021468144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437021468144084370214681448437021468144

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+34 961243225support@quibim.com

Regulatory Flags#

DUNS number
464843370
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
08437021468212QP-Prostate1.72026-06-05
08437021468243QP-Prostate® CAD1.32026-06-05
08437021468045QP-Brain®1.02026-05-06
08437021468236QP-Prostate® CAD1.22026-03-06
08437021468175QP-Prostate1.62025-07-04
08437021468168QP-Prostate® CAD1.12025-05-02
08437021468120QP-Prostate® CAD1.02025-03-28
08437021468052QP-Prostate1.42024-08-01

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