FDA.reportPublic FDA data

Swissmeda powered by Carestream Dental

Primary DI
60192155944543
Brand
Swissmeda powered by Carestream Dental
Company
CARESTREAM DENTAL LLC
Model
5944541
Catalog number
5944541
Device description
Swissmeda powered by Carestream Dental
Published
2022-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K112251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112251000SWISSMEDA DENTAL PLANNING SYSTEMSwissmeda AG2012-01-25LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60192155944543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6019215594454360192155944543

GMDN Terms#

Term, Definition table
TermDefinition
Dental treatment application softwareAn application software program intended to facilitate dental treatment, which may include dental implant and/or oral/maxillofacial surgery planning, by storing/displaying patient demographics/clinical data and treatment plans, and may control settings for dental equipment (e.g., a line-powered dental drilling system). It is typically for installation in an off-the-shelf desktop, laptop or tablet computer, which may require a connection to the dental equipment. It typically includes upgrades to the software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
019796106
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60192155951237CS 9600TP FACE SCAN KIT FOR TP SUPREME 3D2026-05-15
60192155951244CS 9600ADVANCED RADIOLOGY KIT FOR CS 96002026-05-15
60192155008047RVG 6500RVG 6500CIC422018-01-15
60192155008054RVG 6500RVG 6500CIC432018-01-15
60192155008061RVG 6500RVG 6500CIC442018-01-15
60192155319570Dental Imaging SoftwareDental Imaging Software53195792018-01-15
60192155319686CS 9300CS 930053196862018-01-15
60192155319693CS 9300CCS 9300C53196942018-01-15
60192155319716CS 9300 SelectCS 9300 Select53197102018-01-15
60192155319723CS 9300CS 930053197282018-01-15
60192155319730CS 9300CCS 9300C53197362018-01-15
60192155319747CS 9300 SelectCS 9300 Select53197442018-01-15
60192155950438CS 1200CS 12009G52752019-03-01
60192156559807CS 1500CS 150065598012019-03-01
60192156559814CS 1500CS 150065598192019-03-01
60192156559852CS 1500CS 150065598502019-03-01
60192156559999CS 1200CS 120065599912019-02-15
60192156560070CS 1200CS 120065600722019-03-01
60192156851635CS Orthodontic Imaging SoftwareCS Orthodontic Imaging Software10432722018-01-15
60192156851642CS Orthodontic Imaging SoftwareCS Orthodontic Imaging Software17468332018-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
M722CD26103V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.LLZ2026-02-24
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.LLZ2026-01-28