FDA.reportPublic FDA data

IRIS-XP

Primary DI
00191237000069
Brand
IRIS-XP
Company
Medicore Co., Ltd.
Model
IRIS
Catalog number
IRIS
Published
2021-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K212412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212412000IRIS-XPMedicore Co., Ltd.2021-09-13LHQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10191237000066PackageGS11In Commercial Distribution
00191237000069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019123700006610191237000066
00191237000069001912370000691912370000690191237000069

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+823180277070bkyoo@medi-core.com

Regulatory Flags#

DUNS number
688247753
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191237000014SA-3000PSA-3000PSA-3000P2019-04-10
10191237000011SA-3000PSA-3000PSA-3000P2019-04-10
00191237000038Max PulseMax PulseMax Pulse2019-03-05
40191237000036Max PulseMax PulseMax Pulse2019-03-05

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