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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
- 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
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Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- Page Type
- Product Code
- Definition
- A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.
- Physical State
- Software device that receives radiological images as an input and provides the user with the identification and characterization of suspicious lesions as an output.
- Technical Method
- Analyzes radiological images using machine learning algorithms to detect and diagnose lesions suspicious for cancer.
- Target Area
- Anatomical sites that may contain lesions suspicious for cancer.
- Regulation Medical Specialty
- Radiology
- Review Panel
- Radiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 892.2090
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QDQ is linked to regulation 21CFR892.2090, which does not seem to exist yet. It may be pending at the moment.