Anesthesiology
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- MiscellaneousMiscellaneous
- PCSLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox2Product Code
- PDKCream For X-Ray Attenuation2Product Code
- QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture2Product Code
- QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2Product Code
- K242683QP-Prostate® CAD2Cleared 510(K)
- K241770Prostate MR AI (VA10A)2Cleared 510(K)
- K243688Saige-Dx (3.1.0)2Cleared 510(K)
- K241831Transpara (2.1.0)2Cleared 510(K)
- K241747Saige-Dx2Cleared 510(K)
- K240417ProFound Detection (V4.0)2Cleared 510(K)
- K242652Lunit INSIGHT DBT v1.12Cleared 510(K)
- K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)2Cleared 510(K)
- K240301MammoScreen® (3)2Cleared 510(K)
- K231470Lunit INSIGHT DBT2Cleared 510(K)
- K230096Genius AI Detection 2.0 with CC-MLO Correlation2Cleared 510(K)
- K221449Genius AI Detection 2.02Cleared 510(K)
- K221347Transpara 1.7.22Cleared 510(K)
- K212783ProstatID2Cleared 510(K)
- K220105Saige-Dx2Cleared 510(K)
- K210670BU-CAD2Cleared 510(K)
- K211541MammoScreen 2.02Cleared 510(K)
- K211678Lunit INSIGHT MMG2Cleared 510(K)
- K210404Transpara 1.7.02Cleared 510(K)
- K203822ProFound AI Software V3.02Cleared 510(K)
- K201019Genius AI Detection2Cleared 510(K)
- K192854MammoScreen2Cleared 510(K)
- K193229Transpara2Cleared 510(K)
- K192287Transpara2Cleared 510(K)
- K191994ProFound AI Software V2.12Cleared 510(K)
- K182373PowerLook Tomo Detection V2 Software2Cleared 510(K)
- K181704Transpara2Cleared 510(K)
- QJUImage Acquisition And/Or Optimization Guided By Artificial Intelligence2Product Code
- QRNRadiation Therapy Marking Device2Product Code
- KTAMedium, Contrast, RadiologicUProduct Code
- LMZApplicator, Hyperthermia, Interstitial3Product Code
- LNBApplicator, Hyperthermia, Deep Heating, Ultrasound3Product Code
- LNCApplicator, Hyperthermia, Superficial, Rf/Microwave3Product Code
- LOCSystem, Rf/Microwave Hyperthermia, Cancer Treatment3Product Code
- LSYUltrasound, Hyperthermia, Cancer Treatment3Product Code
- MJSContrast Media, Ultrasound3Product Code
- MOTIrradiator, Blood To Prevent Graft Versus Host DiseaseUProduct Code
- NANTester, Acoustic, Bone Quality3Product Code
- NAWMicrospheres Radionuclide3Product Code
- NCLImager, Breast, Electrical Impedance3Product Code
- OLQCross-Sectional Mammographic Xray System3Product Code
- OTEDigital Breast Tomosynthesis3Product Code
- PAAAutomated Breast Ultrasound3Product Code
- QNKOptoacoustic Imaging System3Product Code
- QUVPhase-Changing Fiducial Marker For Radiation Therapy2Product Code
- QVAFludeoxyglucose F18-Guided Radiation Therapy System2Product Code
- QVDRadiological Machine Learning Based Quantitative Imaging Software With Change Control Plan2Product Code
- QXRVaginal Hydrogel Packing System2Product Code
- QVWGenerator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-LedNProduct Code
- QZLPost-Ablation Tissue Response Prediction Software2Product Code
- QWORadiology Software For Referral Of Findings Related To Fibrotic Lung Disease.2Product Code
- SAORadiology Software For Opportunistic Evaluation Of Low Bone Mineral Density2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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MammoScreen 2.0
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K211541
- 510(k) Type
- Traditional
- Applicant
- Therapixel
- Country
- France
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/26/2021
- Days to Decision
- 191 days
- Submission Type
- Summary