FDA.reportPublic FDA data

Meditherm

Primary DI
B7837045001
Brand
Meditherm
Company
Meditherm Incorporated
Model
IRIS 450
Catalog number
1704500
Device description
Thermal Imaging Camera
Published
2022-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K003332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003332000MEDITHERM MED2000Meditherm, Inc.2001-02-21LHQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7837045001PrimaryHIBCC0

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
8453315759info@hudsonvalleybodyworks.com

Regulatory Flags#

DUNS number
118282031
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B783706400170601189MedithermIRIS 64017064002026-05-18
B783706400170601185MedithermIRIS 64017064002026-05-01
B783706400170601158MedithermIRIS 64017064002026-03-31
B783706400170601159MedithermIRIS 64017064002026-03-23
B783706400170601152MedithermIRIS 64017064002026-03-18
B783706400170601154MedithermIRIS 64017064002026-03-18
B783706400170601148MedithermIRIS 64017064002025-12-22
B783706400170601149MedithermIRIS 64017064002025-12-22
B783706400170601151MedithermIRIS 64017064002025-07-30
B783706400170601141MedithermIRIS 64017064002025-07-23
B783706400170601142MedithermIRIS 64017064002025-07-23
B783706400170601145MedithermIRIS 64017064002025-07-23
B783706400170601146MedithermIRIS 64017064002025-07-23
B783706400170601147MedithermIRIS 64017064002025-07-23
B783706400170601132MedithermIRIS 64017064002025-07-02
B783706400170601144MedithermIRIS 64017064002025-07-02
B783706400170601140MedithermIRIS 64017064002025-05-08
B783706400170601143MedithermIRIS 64017064002025-05-08
B783706400170601133MedithermIRIS 64017064002025-02-24
B783706400170601136MedithermIRIS 64017064002025-02-24

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
06429810718044ThermidasTherMidas 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