Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- IYMSystem, Telethermographic, Infrared3Product Code
- KXZSystem, Thermographic, Liquid Crystal, Powered (Adjunctive Use)3Product Code
- KYASystem, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)1Product Code
- LHMSystem, Thermographic, Liquid Crystal1Product Code
- LHPSystem, Telethermographic (Sole Diagnostic Screen)3Product Code
- LHQSystem, Telethermographic (Adjunctive Use)1Product Code
- K232462ThermPix Thermovisual Camera1Cleared 510(K)
- K213650ThermPix Thermovisual Camera1Cleared 510(K)
- K212965Smile-100 System1Cleared 510(K)
- K212412IRIS-XP1Cleared 510(K)
- K200999Thermidas IR System (ThIR-A615)1Cleared 510(K)
- K181716InTouch Thermal Camera1Cleared 510(K)
- K171928Med-Hot Thermal Imaging Systems1Cleared 510(K)
- K162767Sentinel BreastScan II System1Cleared 510(K)
- K160573FirstSense Breast Exam1Cleared 510(K)
- K150457AlfaSight 9000 Thermographic System1Cleared 510(K)
Show All 40 Submissions
- LHRSystem, Thermographic, Liquid Crystal (Sole Diagnostic Screen)3Product Code
- LXEDoppler, Fetal, Ultrasound2Product Code
- MAAMonitor, Fetal Doppler Ultrasound2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
IRIS-XP
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K212412
- 510(k) Type
- Traditional
- Applicant
- Medicore Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/13/2021
- Days to Decision
- 41 days
- Submission Type
- Summary