FDA.reportPublic FDA data

Thermidas

Primary DI
06429810718044
Brand
Thermidas
Company
TherMidas Oy
Model
Thermidas VistaClinic Analyzer
Catalog number
ThAnalyzer
Device description
Thermidas VistaClinic Analyzer is a software app for the analysis of images that have been captured with Thermidas IRT-384 Tablet. The tools include adjustment of color scale, use of regions of interest, zoom & pan, and annotations.
Published
2025-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHQSystem, Telethermographic (Adjunctive Use)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHQSystem, Telethermographic (Adjunctive Use)Obstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200999000Thermidas IR System (ThIR-A615)Thermidas Americas, Inc.2021-01-06LHQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06429810718044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06429810718044064298107180446429810718044

GMDN Terms#

Term, Definition table
TermDefinition
Infrared thermography systemA system using infrared photography or other infrared detection techniques to produce images or graphical representations of the distribution of body surface temperature for the purpose of diagnosing and assessing various conditions and disease states. Also referred to as a thermography scanner. This system typically consists of a camera display unit that includes a scanning-condensing optical system, infrared detector, an operator's console, photographic cameras, black-body phantom, electronic or computerized controls, software and an image display and analysis units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+358403520400juha.hamalainen@thermidas.fi

Regulatory Flags#

DUNS number
540505042
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06429810718037ThermidasThermidas IRT-384 TabletThIRT-3842025-04-08
06429810718020ThermidasThermidas IR CameraThIRT-3842023-08-03
06429810718013ThermidasThermidas Remote SWThRemote2023-08-03
06429810718006ThermidasThermidas IR SystemThIR-A6152023-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B783706400170601189MedithermMeditherm IncorporatedLHQ2026-05-18
B783706400170601185MedithermMeditherm IncorporatedLHQ2026-05-01
B783706400170601158MedithermMeditherm IncorporatedLHQ2026-03-31
B783706400170601159MedithermMeditherm IncorporatedLHQ2026-03-23
B783706400170601152MedithermMeditherm IncorporatedLHQ2026-03-18
B783706400170601154MedithermMeditherm IncorporatedLHQ2026-03-18
00860008801906ThermPixUSA THERM, INC.LHQ2026-01-27
B783706400170601148MedithermMeditherm IncorporatedLHQ2025-12-22
B783706400170601149MedithermMeditherm IncorporatedLHQ2025-12-22
08908019450118BreastHealth-100NIRAMAI HEALTH ANALYTIX PRIVATE LIMITEDLHQ2025-11-21
B783706400170601151MedithermMeditherm IncorporatedLHQ2025-07-30
B783706400170601141MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601142MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601145MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601146MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601147MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601132MedithermMeditherm IncorporatedLHQ2025-07-02
B783706400170601144MedithermMeditherm IncorporatedLHQ2025-07-02
B783706400170601140MedithermMeditherm IncorporatedLHQ2025-05-08
B783706400170601143MedithermMeditherm IncorporatedLHQ2025-05-08
06429810718037ThermidasTherMidas OyLHQ2025-04-08
B783706400170601133MedithermMeditherm IncorporatedLHQ2025-02-24
B783706400170601136MedithermMeditherm IncorporatedLHQ2025-02-24
B783706400170601137MedithermMeditherm IncorporatedLHQ2025-02-24
08908019450057SMILE-100 SystemNIRAMAI HEALTH ANALYTIX PRIVATE LIMITEDLHQ2025-02-18
B783706400170601138MedithermMeditherm IncorporatedLHQ2024-10-25
B783706400170601135MedithermMeditherm IncorporatedLHQ2024-09-09
10853818007504USB C AdapterPRECISION BIOMETRICS INCLHQ2024-09-03
00853818007491USB A to C CablePRECISION BIOMETRICS INCLHQ2024-09-03
00853818007507USB C to C CablePRECISION BIOMETRICS INCLHQ2024-09-03