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- MiscellaneousMiscellaneous
- MAODna-Probe, Human ChromosomeUProduct Code
- MKQProcessor, Cervical Cytology Slide, Automated3Product Code
- MNMReader, Cervical Cytology Slide, Automated3Product Code
- MTIKit, Cell Screening, FetalNProduct Code
- MVCSystem, Test, Her-2/Neu, Ihc3Product Code
- MVDSystem, Test, Her-2/Neu, Nucleic Acid Or Serum3Product Code
- NSDTest, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence3Product Code
- NXGFluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion3Product Code
- OQSLaboratory Developed TestNProduct Code
- OTUResearch Use Only/PathologyNProduct Code
- OWEFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement3Product Code
- PANBraf Mutation KitNProduct Code
- PDDInvestigational Use Only - PathologyNProduct Code
- PFUTissue Processing KitNProduct Code
- PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection3Product Code
- PJGCancer-Related Germline Gene Mutation Detection System3Product Code
- PKWImmunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase3Product Code
- PLSImmunohistochemistry Assay, Antibody, Programmed Death-Ligand 13Product Code
- PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System3Product Code
- QFISynthetic Next-Generation Sequencing Quality Control And Filler MaterialNProduct Code
- QFKTumor Gene Profiling TestNProduct Code
- QQTImmunohistochemistry Assay, Antibody, Ki-673Product Code
- QSACirculating Tumor Cell (Ctc) Enrichment Device2Product Code
- QVUHigh Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.2Product Code
- QYVDigital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm2Product Code
- SBBSystem, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection3Product Code
- SBYHigh Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids2Product Code
- SFSRevumenib Eligibility Detection System2Product Code
- SFHPathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis2Product Code
- SFLIdylla Cdx Msi Test3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
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Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis
- Page Type
- Product Code
- Definition
- A pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from prostate biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.
- Physical State
- Software device that receives digitized pathology glass slide images as an input and provides the user with prognostic risk estimates (e.g., Distant Metastasis).
- Technical Method
- Analyzes digitized pathology glass slide images using machine learning algorithms to provide prognostic risk estimates.
- Target Area
- Human tissue biopsy images
- Regulation Medical Specialty
- Pathology
- Review Panel
- Pathology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 864.3755
- 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 SFH is linked to regulation 21CFR864.3755, which does not seem to exist yet. It may be pending at the moment.