FDA.reportPublic FDA data

DTX Studio™ Assist

Primary DI
07332747221862
Brand
DTX Studio™ Assist
Company
Nobel Biocare AB
Model
1.1
Catalog number
302261
Device description
DTX Studio Assist 1.1 for Mac
Published
2025-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYNAnalyzer, medical image
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYNAnalyzer, Medical ImageRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252086000DTX Studio AssistNobel Biocare C/O Medicim NV2025-11-17MYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332747221862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332747221862073327472218627332747221862

GMDN Terms#

Term, Definition table
TermDefinition
Dental clinical assessment support radiology softwareA software program intended to display, analyse/process, and possibly acquire images of the teeth/gums, and typically surrounding region, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of a dental condition. The images are typically acquired via x-ray [e.g., cone beam computed tomography (CBCT)] or by an intraoral camera. It is not dedicated to surgical planning or navigation, and does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

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

Regulatory Flags#

DUNS number
353939929
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332747221855DTX 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
07332747236620DTX Studio™ Clinic4.83008512026-03-27

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08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
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08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07
04068151012453syngo.CT Coronary CockpitSiemens Healthcare GmbHQIH2026-07-17
04068151034202syngo DynamicsSiemens Healthineers AGQIH2026-07-16
04068151086584LungMapsSiemens Healthineers AGQIH2026-06-24
03663999000429VEA AlignEOS IMAGINGQIH2026-06-12
04068151049923MI View&GOSIEMENS MEDICAL SOLUTIONS USA, INC.QIH2026-06-10
04262352357935DS Core DetectZetta25 AGMYN2026-06-03
04068151018226syngo Application SoftwareSiemens Healthcare GmbHQIH2026-05-15
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00860013927820Overjet Iris Intelligent Imaging SystemOverjet, Inc.QIH2026-05-13
08437021722093ADAS 3DADAS3D MEDICAL S.L.QIH2026-05-12
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04262352351605DS Core DiagnosisZetta25 AGQIH2026-04-30
08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23
00860015071101SugarBotBENCH7 INC.MYN2026-04-08
08800124700136SwiftMRAIRS Medical Inc.QIH2026-04-01
G703AIORTAPLAN0AiORTA - PlanVitaa Medical Solutions Inc.QIH2026-03-30
08800066200626MEDIHUB PROSTATEJLK, Inc.QIH2026-03-25
00884838122154EchoNavigatorPhilips Medical Systems Nederland B.V.QIH2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.QIH2026-02-24
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
05070003179800CDM InsightsOXFORD BRAIN DIAGNOSTICS LTDQIH2026-01-26
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-01-20