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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
- 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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Post-Ablation Tissue Response Prediction Software
- Page Type
- Product Code
- Definition
- A Post-ablation tissue response prediction software is an image processing device intended to aid physicians with adjunctive information in their clinical assessment of the ablation zone following a tissue ablation procedure. This device uses information extracted from medical images along with other clinical data to predict the ablation zone post treatment.
- Physical State
- Software device
- Technical Method
- Medical images are analyzed for prediction of ablation zone post treatment.
- Target Area
- The device operates on radiological images of the human body.
- Regulation Medical Specialty
- Radiology
- Review Panel
- Radiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 892.2052
- 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 QZL is linked to regulation 21CFR892.2052, which does not seem to exist yet. It may be pending at the moment.