FDA.reportPublic FDA data

Planmeca Romexis

Primary DI
06430035420599
Brand
Planmeca Romexis
Company
Planmeca Oy
Model
6
Catalog number
10041546
Device description
Planmeca Romexis is a modular imaging software for dental and medical use.
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K200572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200572000Planmeca RomexisPlanmeca Oy2020-12-02LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035420599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035420599064300354205996430035420599

GMDN Terms#

Term, Definition table
TermDefinition
Panoramic/tomographic dental x-ray system application softwareAn application or operating data program designed for use in, or together with a panoramic/tomographic dental x-ray system configuration. A basic set of applications programs and routines are included with any computer-controlled diagnostic imaging system. Some applications software routines or groups of routines (packages) must be combined with specific hardware or firmware accessories or 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

Regulatory Flags#

DUNS number
368788568
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430035420292Planmeca ProMaxProMax 2D100306882016-08-10
06430035420988Planmeca VisoG5 (G3)30048120, 30035196, 30016794, 30054720, 30064043, 2024-01-10
06430035420322Planmeca ProOneProOne30010469, 30054727, 300547352016-08-10
06430035420360Planmeca IntraProX10029551, 30054728, 30054748, 30054749, 30054750, 2016-08-10
06430035420445Planmeca ProMaxProMax 2D30003108, 30054723, 30064278, 30054724, 30054736, 2016-09-19
06430035420452Planmeca ProMaxProMax 2D30003107, 30054725, 30064279, 30054726, 30054738, 2016-09-19
06430035420476Planmeca ProMaxProMax 3D30003109, 30054721, 30064042, 30054722, 30054744, 2016-09-19
06430035420995Planmeca VisoG730048121,30016793, 300642692024-01-10
06430035420483Planmeca ProMaxProMax 3D Plus30016946, 30054717, 30054719, 30064041, 30054740, 2016-09-19
06430035420490Planmeca ProMaxProMax 3D Mid30003112, 30054742, 300547432016-09-19
06430035420551Planmeca VisoG730004941,30064509, 300547322018-09-21
06430035420100Planmeca SovereignClassic10032746, 100327472017-05-05
06430035420346Planmeca ProMaxProMax 3D300169432016-08-10
06430035420353Planmeca ProMaxProMax 3D Max100200192016-08-10
06430035420469Planmeca ProMaxProMax 3D300169452016-09-19
06430035420506Planmeca ProMaxProMax 3D Max300031142016-09-19
06430035420513Planmeca ProMaxProMax 3D Max300031152016-09-19
06430035420964Planmeca Pro50 Chair-2022-12-19
06430035420162Planmeca ChairChair100260002017-05-08
06430035420407Planmeca ProMaxProMax 3D Plus300169442016-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
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