FDA.reportPublic FDA data

Thermoguide Workstation

Primary DI
17340007000833
Brand
Thermoguide Workstation
Company
Clinical Laserthermia Systems AB
Model
1100-N1
Published
2022-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ONONeurosurgical Laser With Mr Thermography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONONeurosurgical Laser With Mr ThermographyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214125000TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB2022-09-22ONO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17340007000833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1734000700083317340007000833

GMDN Terms#

Term, Definition table
TermDefinition
MRI system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) 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 applications software programs or program 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

Regulatory Flags#

DUNS number
774856749
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17340007000840Laser Applicator Non-cooled4012-N52022-10-28
17340007000857Laser Applicator Non-cooled4017-N22022-10-28
17340007000864Laser Applicator Non-cooled4017-N42022-10-28
17340007000956MR Introducer4013-N62024-05-07
17340007000826Mobile Laser Unit1001-N22022-10-28
17340007000659Tissue Temp Probe3001-012022-10-28
17340007000666Tissue Temp Probe3001-022022-10-28
17340007000673Tissue Temp Probe3002-012022-10-28
17340007000680Tissue Temp Probe3002-022022-10-28
17340007000697Tissue Temp Probe3003-012022-10-28
17340007000703Tissue Temp Probe3003-022022-10-28
17340007000710Tissue Temp Probe3004-012022-10-28
17340007000727Tissue Temp Probe3004-022022-10-28
17340007000611Mobile Laser Unit1001-022022-10-28
17340007000871Instructions for use Tranberg Thermoguide Therapy System - USL-2019-0622022-10-28
17340007000017Mobile Laser Unit1001-012016-09-18
17340007000024Tissue Temp Probe3101-012016-09-18
17340007000031Tissue Temp Probe3101-022016-09-18
17340007000048Tissue Temp Probe3201-012016-09-18
17340007000055Tissue Temp Probe3102-012016-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000540104VisualaseMEDTRONIC NAVIGATION, INC.ONO2026-03-27
00763000540111VisualaseMEDTRONIC NAVIGATION, INC.ONO2026-03-27
00763000540128VisualaseMEDTRONIC NAVIGATION, INC.ONO2026-03-27
00763000521486Visualase V2 MRI-Guided Laser Ablation SystemMEDTRONIC NAVIGATION, INC.ONO2026-02-02
00763000521370VISUALASEMEDTRONIC NAVIGATION, INC.ONO2024-08-03
17340007000956MR IntroducerClinical Laserthermia Systems ABONO2024-05-07
37340007000950MR IntroducerClinical Laserthermia Systems ABONO2024-05-07
00816589021585NeuroBlate NB3 FullFire™ 1.6 Laser ProbeMONTERIS MEDICAL INCONO2024-01-02
17340007000840Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
17340007000857Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
17340007000864Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
17340007000826Mobile Laser UnitClinical Laserthermia Systems ABONO2022-10-28
37340007000844Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
37340007000851Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
37340007000868Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
17340007000871Instructions for use Tranberg Thermoguide Therapy System - USClinical Laserthermia Systems ABONO2022-10-28
17340007000888Instructions for Use Laser applicator - NeuroClinical Laserthermia Systems ABONO2022-10-28
00763000521462VisualaseMEDTRONIC NAVIGATION, INC.ONO2022-04-03
00763000416423VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-10-02
00763000416430VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-10-02
00763000416447VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-10-02
00763000402082VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-05-06
00763000402099VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-01-29
00763000313364VisualaseMEDTRONIC NAVIGATION, INC.ONO2020-06-27
00763000357504VisualaseMEDTRONIC NAVIGATION, INC.ONO2020-05-17
00763000218171VisualaseMEDTRONIC NAVIGATION, INC.ONO2019-03-21
00763000218188VisualaseMEDTRONIC NAVIGATION, INC.ONO2019-03-18
00643169933361VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-11
00643169933385VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-11
00643169792890VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-09