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)
- K113259NOTOUCH BREASTSCAN1Cleared 510(K)
- K101641AG THERMOGRAPHIC CAMERA, MODEL ATIR-M3011Cleared 510(K)
- K073581ICI P AND S SERIES IR CAMERAS1Cleared 510(K)
- K063047MEDHOT MTI 2000 THERMAL IMAGING SYSTEM1Cleared 510(K)
- K050239EMD THERMOGRAPHY SYSTEM1Cleared 510(K)
- K033967TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P1Cleared 510(K)
- K032350INFRARED SCIENCES BREASTSCAN IR SYSTEM1Cleared 510(K)
- K032471TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM1Cleared 510(K)
- K030165THERMATREK IRIS-IV INFRARED IMAGING SYSTEM1Cleared 510(K)
- K030018MHS 70001Cleared 510(K)
- K023925MARK I THERMAL IMAGER1Cleared 510(K)
- K023434DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM1Cleared 510(K)
- K020783TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB1Cleared 510(K)
- K011981MHS 50001Cleared 510(K)
- K003332MEDITHERM MED20001Cleared 510(K)
- K003130REGUTHERM 952 THERMOGRAPHIC SYSTEM1Cleared 510(K)
- K990416OMNICORDER BIOSCAN SYSTEM1Cleared 510(K)
- K982112THERMATREK IRIS-3 INFRARED IMAGING SYSTEM1Cleared 510(K)
- K982327INFRAMETRICS INFRACAM-MED1Cleared 510(K)
- K971956CRT2000 THERMOGRAPHIC SYSTEM1Cleared 510(K)
- K951806OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)1Cleared 510(K)
- K897191BSI MODEL TIP1Cleared 510(K)
- K895358THERMO-50001Cleared 510(K)
- K863818PM-100 THERMOGRAPH MARK 10261Cleared 510(K)
- K861534MODEL 450 INFRARED IMAGING SYSTEM1Cleared 510(K)
- K842878GST SYSTEM THERMOGRAPHIC APPLICATION1Cleared 510(K)
- K850534BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM1Cleared 510(K)
- K844771INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM1Cleared 510(K)
- K843549PROBEYE THERMAL VIDEO SYSTEMS1Cleared 510(K)
- K841271INFRA-EYE 1601Cleared 510(K)
- 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
OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K951806
- 510(k) Type
- Traditional
- Applicant
- OPGAL OPTRONIC INDUSTRIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/6/1995
- Days to Decision
- 78 days
- Submission Type
- Summary