FDA.reportPublic FDA data

CAAS Workstation

Primary DI
08056304453099
Brand
CAAS Workstation
Company
Pie Medical Imaging B.V.
Model
7.4
Published
2016-09-27
Public version status
Update
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
K151780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151780000CAAS WorkstationPie Medical Imaging BV2016-03-11IZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056304453099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056304453099080563044530998056304453099

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 manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31308500202support@pie.nl

Regulatory Flags#

DUNS number
413761941
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
080563044562053mensio Workstation10.92026-07-08
080563044559253mensio Workstation10.72025-04-29
080563044555053mensio Workstation10.62024-04-05
08056304454706CAAS MR Solutions5.32023-12-21
08056304455864Caas Qardia2.22026-04-03
08056304456014CAAS Workstation9.32025-11-24
08056304455772CAAS Workstation9.22024-08-22
08056304455369Caas Qardia2.12023-12-20
08056304454256CAAS MR Solution5.22020-11-13
08056304454270CAAS A-Valve2.1 2020-05-19
080563044543483mensio Workstation 10.22020-11-17
08056304454768CAAS Qardia1.12023-01-13
08056304454928CAAS Qardia2.02023-01-13
080563044549423mensio Workstation10.42023-04-17
08056304455314CAAS Workstation8.5.32022-11-03
080563044546693mensio Workstation10.32021-12-23
08056304454461CAAS Workstation8.52021-05-21
08056304454331CAAS Workstation8.42020-07-01
080563044542493mensio Workstation10.12020-01-24
08056304453044CAAS MRV4.22017-01-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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