FDA.reportPublic FDA data

NobelClinician®

Primary DI
07332747125153
Brand
NobelClinician®
Company
Nobel Biocare AB
Model
3.1
Catalog number
101560
Device description
NobelClinician 3.1 for Windows 32-bit
Published
2017-02-27
Public version status
Update
Distribution status
Not 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
K163122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163122000NobelClinician, DTX Studio implantNobel Biocare AB2017-01-31LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332747125153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332747125153073327471251537332747125153

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose dental x-ray system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-5001us.customerservice@nobelbiocare.com

Regulatory Flags#

DUNS number
353939929
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332747221855DTX Studio™ Assist1.13022612025-12-01
07332747221862DTX Studio™ Assist1.13022612025-12-01
07332747086904NA37677376772022-07-25
07332747225433NobelProcera®NBRA_FDATEST_2NBRA_FDATEST_22025-05-08
07332747214918Nobel Biocare®3019313019312026-04-09
07332747214925Nobel Biocare®3019323019322026-04-09
07332747214932Nobel Biocare®3019333019332026-04-09
07332747214949Nobel Biocare®3019343019342026-04-09
07332747221510Nobel Biocare®3022543022542026-04-09
07332747221527Nobel Biocare®3022553022552026-04-09
07332747221534Nobel Biocare®3022563022562026-04-09
07332747223385Nobel Biocare®3022653022652026-04-09
07332747223392Nobel Biocare®3022643022642026-04-09
07332747223408Nobel Biocare®3022663022662026-04-09
07332747224436Nobel Biocare®3024853024852026-04-09
07332747224443Nobel Biocare®3024863024862026-04-09
07332747224450Nobel Biocare®3024883024882026-04-09
07332747224467Nobel Biocare®3024873024872026-04-09
07332747224474Nobel Biocare®3024893024892026-04-09
07332747224481Nobel Biocare®3024903024902026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
05745000308323Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-01-30
05745000308330Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-01-30
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00195278951700EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00195278951717EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
03663999000375spineEOSEOS IMAGINGLLZ2025-08-01
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
07613252196259FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29