Review Panel
Pathology FDA 510(k) Clearances & Devices
- Cleared Devices
- 343
- Product Codes (page)
- 36
- Latest Decision
- 2026-09-25
Clearances · page 1 of 4
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K260023 | TumorSight Risk | SimBioSys, Inc. | SHW | Class II | 2026-09-25 |
| K253561 | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | SIX | Class II | 2026-08-07 |
| K253554 | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | PSY | Class II | 2026-08-07 |
| K261380 | Concentriq AP-Dx | Proscia, Inc. | QKQ | Class II | 2026-08-05 |
| K260964 | NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. | PSY | Class II | 2026-07-22 |
| K251952 | Virasight | Virasoft Corporation | PSY | Class II | 2026-07-17 |
| K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | PSY | Class II | 2026-07-15 |
| K260235 | CellDx-Tissue | Datar Cancer Genetics Private Limited | PZM | Class II | 2026-05-12 |
| K254115 | ArteraAI Breast | Artera, Inc. | SHW | Class II | 2026-05-04 |
| K243449 | INFINITT DPS | Infinitt Healthcare Co., Ltd. | QKQ | Class II | 2025-12-09 |
| K252762 | HALO AP Dx | Indica Labs, LLC | QKQ | Class II | 2025-11-25 |
| K241868 | xR IVD | Tempus AI, Inc. | PZM | Class II | 2025-09-19 |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology, Inc. | PZM | Class II | 2025-08-29 |
| DEN240068 | ArteraAI Prostate | Artera, Inc. | SFH | Class II | 2025-07-31 |
| K243391 | AISight Dx | PathAI, Inc. | QKQ | Class II | 2025-06-26 |
| K250968 | PathPresenter Clinical Viewer | Pathpresenter Corporation | QKQ | Class II | 2025-06-20 |
| K242545 | RadiForce MX317W-PA | Eizo Corporation | PZZ | Class II | 2025-05-23 |
| K250414 | CaloPix | Tribun Health | QKQ | Class II | 2025-05-14 |
| K242244 | Viewer+ | Lumea, Inc. | QKQ | Class II | 2025-03-14 |
| K243871 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | PSY | Class II | 2025-03-06 |
| K241717 | E1000 Dx Digital Pathology Solution | Shandon Diagnostics Limited | PSY | Class II | 2025-02-28 |
| K241232 | Galen Second Read | Ibex Medical Analytics , Ltd. | QPN | Class II | 2025-01-24 |
| K241273 | FullFocus | Paige.Ai, Inc. | QKQ | Class II | 2025-01-09 |
| K233119 | 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T | Shenzhen Beacon Display Technology Co., Ltd. | PZZ | Class II | 2024-12-28 |
| K242783 | Roche Digital Pathology Dx | Ventana Medical Systems, Inc. | PSY | Class II | 2024-12-17 |
| K242848 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | PSY | Class II | 2024-12-10 |
| K241871 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | Class II | 2024-12-02 |
| K243222 | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) | Biofire Diagnostics, LLC (Biomerieux) | QDS | Class II | 2024-11-06 |
| K240303 | MetaLite DX Digital Pathology Software | Jellox Biotech, Inc. | QKQ | Class II | 2024-10-28 |
| DEN230046 | PGDx elio plasma focus Dx | Personal Genome Diagnostics, Inc. | SBY | Class II | 2024-08-01 |
| K233204 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | PSY | Class II | 2024-06-24 |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | Ventana Medical Systems, Inc. | PSY | Class II | 2024-06-14 |
| K233126 | aetherSlide | Aetherai Co., Ltd. | QKQ | Class II | 2024-05-30 |
| K232833 | HALO AP Dx | Indica Labs, Inc. | PSY | Class II | 2024-05-07 |
| K232208 | Sectra Digital Pathology Module (Version 3.3) | Sectra AB | PSY | Class II | 2024-04-16 |
| K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | PSY | Class II | 2024-04-16 |
| K230839 | Concentriq Dx | Proscia, Inc. | PSY | Class II | 2024-02-08 |
| DEN210035 | Genius Digital Diagnostics System with the Genius Cervical AI algorithm | Hologic, Inc. | QYV | Class II | 2024-01-31 |
| K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | PSY | Class II | 2023-12-22 |
| DEN210011 | Invitae Common Hereditary Cancers Panel | Invitae Corporation | QVU | Class II | 2023-09-29 |
| K210017 | ACTOnco, ACTOnco IVD | Act Genomics | PZM | Class II | 2022-12-23 |
| K222601 | FilmArray Pneumonia Panel plus | Biofire Diagnostics, LLC | QDS | Class II | 2022-10-27 |
| K213883 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | PSY | Class II | 2022-09-27 |
| K212361 | Novo | PathAI, Inc. | QKQ | Class II | 2022-08-11 |
| K210811 | Dynamyx Digital Pathology Software | Inspirata, Inc. | QKQ | Class II | 2022-03-01 |
| K212176 | CINtec Histology | Ventana Medical Systems, Inc. | PRB | Class II | 2021-12-10 |
| DEN200080 | Paige Prostate | Paige.Ai | QPN | Class II | 2021-09-21 |
| K203845 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | Class II | 2021-09-17 |
| K202304 | NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) | Nyu Langone Medical Center | PZM | Class II | 2021-07-14 |
| K203364 | MDPC-8127 | Barco N.V. | PSY | Class II | 2021-04-15 |
| K200009 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | QDC | Class II | 2020-08-05 |
| K201005 | FullFocus | Paige.Ai, Inc. | QKQ | Class II | 2020-07-15 |
| K192063 | PGDx elio tissue complete | Personal Genome Diagnostics | PZM | Class II | 2020-04-24 |
| K193054 | Sectra Digital Pathology Module | Sectra AB | QKQ | Class II | 2020-03-31 |
| K190661 | Omics Core | Nanthealth, Inc. | PZM | Class II | 2019-11-09 |
| K192259 | Philips IntelliSite Pathology Solution | Philips Electronics Nederland B.V. | PSY | Class II | 2019-09-20 |
| K190332 | Aperio AT2 DX System | Leica Biosystems Imaging, Inc. | PSY | Class II | 2019-05-20 |
| K181324 | FilmArray Pneumonia Panel plus | Biofire Diagnostics, LLC | QDS | Class II | 2018-11-15 |
| DEN170080 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | QDC | Class II | 2018-09-28 |
| K172922 | MMPC-4127F1 | Barco N.V. | PZZ | Class II | 2017-12-21 |
| DEN170017 | FilmArray Respiratory Panel 2 plus (RP2plus) | Biofire Diagnostics, LLC | PZF | Class II | 2017-11-24 |
| DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay | Memorial Sloan-Kettering Cancer Center | PZM | Class II | 2017-11-15 |
| K172174 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | Class II | 2017-10-04 |
| DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | Class II | 2017-04-12 |
| DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) | Ventana Medical Systems, Inc. | PRB | Class II | 2017-03-04 |
| K970580 | SASI-DC1TS | Substance Abuse Specialties, Inc. | KDW | Class I | 1997-04-17 |
| K955362 | INCSTAR HSV I/II IGG FAST ELISA ASSAY | Incstar Corp. | IGC | Class I | 1996-07-24 |
| K955363 | INCSTAR HSZ I/II IGG ELISA ASSAY | Incstar Corp. | IGC | Class I | 1996-07-24 |
| K950560 | SALINE SOLUTINE, STERILE | Busse Hospital Disposables, Inc. | IGE | Class I | 1995-05-30 |
| K951122 | CAPITOL URINE DRUG SCREEN COLLECTION KIT | Harry A. Schlakman | KDW | Class I | 1995-05-05 |
| K940768 | AD PERFECT | Chimera Research & Chemical, Inc. | IFT | Class I | 1995-02-17 |
| K931474 | DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS | Gbf Medical Group | KDW | Class I | 1994-05-10 |
| K933996 | PROFIBLOT | Tecan U.S., Ltd. | KPA | Class I | 1994-01-28 |
| K924590 | MICROWAVE AUTOMATED TISSUE PROCESSOR | Innovative Medical Systems, Inc. | IEO | Class I | 1992-12-29 |
| K913967 | DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM | Doxtech, Inc. | KDW | Class I | 1991-10-18 |
| K900983 | TRI-TECH URINE SPECIMEN KIT | Tri-Tech, Inc. | FMH | Class I | 1990-09-17 |
| K893772 | TISSUE EMBEDDING MEDIUM | Stephens Scientific | KEO | Class I | 1989-06-22 |
| K891604 | THE CEN-SLIDE(TM) CENTRIFUGE TUBE | Davstar California, Inc. | KEW | Class I | 1989-06-16 |
| K885091 | HEMAVIEW DARKFIELD MICROSCOPE SYSTEM | Technalysis, Inc. | IBM | Class I | 1989-06-13 |
| K890984 | LINISTAIN SLS | Shandon, Inc. | KIO | Class I | 1989-04-04 |
| K890042 | MICROSCOPE SLIDES PRECOATED | Stat Path | KEW | Class I | 1989-01-13 |
| K884755 | CONSED FECAL CONCENTRATION SYSTEM | Donald L. Price, Ph.D. | IFP | Class I | 1989-01-10 |
| K890022 | ATS MAYER'S ALBUMIN | Alpha-Tec Systems, Inc. | KEL | Class I | 1989-01-10 |
| K884258 | VERSABLOT | American Bionetics, Inc. | KPA | Class I | 1988-12-14 |
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Innovative Medical Systems, Inc. | IEO | Class I | 1988-09-02 |
| K883514 | EXAKT CUTTING & GRINDING SYSTEM | Exakt Medical Instruments, Inc. | IDP | Class I | 1988-08-29 |
| K883048 | ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION | Alpha-Tec Systems, Inc. | LDZ | Class I | 1988-08-17 |
| K883062 | ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID | Alpha-Tec Systems, Inc. | LDW | Class I | 1988-08-04 |
| K882874 | ZINC FORMALIN | Anatech, Ltd. | LDX | Class I | 1988-07-28 |
| K882881 | SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER | Sakura Finetek U.S.A., Inc. | KES | Class I | 1988-07-28 |
| K881165 | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR | Sakura Finetek U.S.A., Inc. | IEO | Class I | 1988-07-01 |
| K882357 | MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY | Stat Path | KEW | Class I | 1988-06-16 |
| K882268 | ZINC FORMALIN CONCENTRATE | Anatech, Ltd. | IGG | Class I | 1988-06-15 |
| K881922 | CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE | Surgipath Medical Industries, Inc. | LDZ | Class I | 1988-05-25 |
| K881592 | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER | Wescor, Inc. | KPA | Class I | 1988-05-13 |
| K881698 | ATS PVA FIXATIVE SOLUTION | Alpha-Tec Systems, Inc. | LDZ | Class I | 1988-05-13 |
| K880745 | LX-100 SLIDE STAINER | Innovative Medical Systems, Inc. | KPA | Class I | 1988-04-27 |
| K874750 | VIDEO ANALYZER 4000 | Scientific Imaging, Inc. | IBJ | Class I | 1988-04-25 |
| K881659 | TISSUE SECTION ADHESIVE | Surgipath Medical Industries, Inc. | IFZ | Class I | 1988-04-21 |
| K881477 | HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED | Stat Path | KEL | Class I | 1988-04-18 |
343 clearances in the Pathology panel. Data: openFDA.