| Aperio GT 450 DX; Aperio GT 180 DX (K253554) | Leica Biosystems Imaging, Inc. | 2026-08-07 |
| Aperio iQC DX Software (K253561) | Leica Biosystems Imaging, Inc. | 2026-08-07 |
| Concentriq AP-Dx (K261380) | Proscia, Inc. | 2026-08-05 |
| NanoZoomer S540MD Slide Scanner System (K260964) | Hamamatsu Photonics K.K. | 2026-07-22 |
| Virasight (K251952) | Virasoft Corporation | 2026-07-17 |
| NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system (K253606) | Hamamatsu Photonics K.K. | 2026-07-15 |
| CellDx-Tissue (K260235) | Datar Cancer Genetics Private Limited | 2026-05-12 |
| ArteraAI Breast (K254115) | Artera, Inc. | 2026-05-04 |
| INFINITT DPS (K243449) | Infinitt Healthcare Co., Ltd. | 2025-12-09 |
| HALO AP Dx (K252762) | Indica Labs, LLC | 2025-11-25 |
| xR IVD (K241868) | Tempus AI, Inc. | 2025-09-19 |
| GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) (K250003) | Geneseeq Technology, Inc. | 2025-08-29 |
| ArteraAI Prostate (DEN240068) | Artera, Inc. | 2025-07-31 |
| AISight Dx (K243391) | PathAI, Inc. | 2025-06-26 |
| PathPresenter Clinical Viewer (K250968) | Pathpresenter Corporation | 2025-06-20 |
| RadiForce MX317W-PA (K242545) | Eizo Corporation | 2025-05-23 |
| CaloPix (K250414) | Tribun Health | 2025-05-14 |
| Viewer+ (K242244) | Lumea, Inc. | 2025-03-14 |
| Philips IntelliSite Pathology Solution 5.1 (K243871) | Philips Medical Systems Nederland B.V. | 2025-03-06 |
| E1000 Dx Digital Pathology Solution (K241717) | Shandon Diagnostics Limited | 2025-02-28 |
| Galen™ Second Read™ (K241232) | Ibex Medical Analytics , Ltd. | 2025-01-24 |
| FullFocus (K241273) | Paige.Ai, Inc. | 2025-01-09 |
| 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T (K233119) | Shenzhen Beacon Display Technology Co., Ltd. | 2024-12-28 |
| Roche Digital Pathology Dx (K242783) | Ventana Medical Systems, Inc. | 2024-12-17 |
| Philips IntelliSite Pathology Solution 5.1 (K242848) | Philips Medical Systems Nederland B.V. | 2024-12-10 |
| Philips IntelliSite Pathology Solution (K241871) | Philips Medical Systems Nederland B.V. | 2024-12-02 |
| BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) (K243222) | Biofire Diagnostics, LLC (Biomerieux) | 2024-11-06 |
| MetaLite DX Digital Pathology Software (K240303) | Jellox Biotech, Inc. | 2024-10-28 |
| PGDx elio plasma focus Dx (DEN230046) | Personal Genome Diagnostics, Inc. | 2024-08-01 |
| Philips IntelliSite Pathology Solution 5.1 (K233204) | Philips Medical Systems Nederland B.V. | 2024-06-24 |
| Roche Digital Pathology Dx (VENTANA DP 200) (K232879) | Ventana Medical Systems, Inc. | 2024-06-14 |
| aetherSlide (K233126) | Aetherai Co., Ltd. | 2024-05-30 |
| HALO AP Dx (K232833) | Indica Labs, Inc. | 2024-05-07 |
| Sectra Digital Pathology Module (Version 3.3) (K232208) | Sectra AB | 2024-04-16 |
| Aperio GT 450 DX (K232202) | Leica Biosystems Imaging, Inc. | 2024-04-16 |
| Concentriq Dx (K230839) | Proscia, Inc. | 2024-02-08 |
| “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” (DEN210035) | Hologic, Inc. | 2024-01-31 |
| NanoZoomer S360MD Slide scanner system (K233027) | Hamamatsu Photonics K.K. | 2023-12-22 |
| Invitae Common Hereditary Cancers Panel (DEN210011) | Invitae Corporation | 2023-09-29 |
| ACTOnco, ACTOnco IVD (K210017) | Act Genomics | 2022-12-23 |
| FilmArray Pneumonia Panel plus (K222601) | Biofire Diagnostics, LLC | 2022-10-27 |
| NanoZoomer S360MD Slide scanner system (K213883) | Hamamatsu Photonics K.K. | 2022-09-27 |
| Novo (K212361) | PathAI, Inc. | 2022-08-11 |
| Dynamyx Digital Pathology Software (K210811) | Inspirata, Inc. | 2022-03-01 |
| CINtec Histology (K212176) | Ventana Medical Systems, Inc. | 2021-12-10 |
| Paige Prostate (DEN200080) | Paige.Ai | 2021-09-21 |
| Philips IntelliSite Pathology Solution (K203845) | Philips Medical Systems Nederland B.V. | 2021-09-17 |
| NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) (K202304) | Nyu Langone Medical Center | 2021-07-14 |
| MDPC-8127 (K203364) | Barco N.V. | 2021-04-15 |
| Adaptive Biotechnologies clonoSEQ Assay (K200009) | Adaptive Biotechnologies Corporation | 2020-08-05 |
| FullFocus (K201005) | Paige.Ai, Inc. | 2020-07-15 |
| PGDx elio tissue complete (K192063) | Personal Genome Diagnostics | 2020-04-24 |
| Sectra Digital Pathology Module (K193054) | Sectra AB | 2020-03-31 |
| Omics Core (K190661) | Nanthealth, Inc. | 2019-11-09 |
| Philips IntelliSite Pathology Solution (K192259) | Philips Electronics Nederland B.V. | 2019-09-20 |
| Aperio AT2 DX System (K190332) | Leica Biosystems Imaging, Inc. | 2019-05-20 |
| FilmArray Pneumonia Panel plus (K181324) | Biofire Diagnostics, LLC | 2018-11-15 |
| Adaptive Biotechnologies clonoSEQ Assay (DEN170080) | Adaptive Biotechnologies Corporation | 2018-09-28 |
| MMPC-4127F1 (K172922) | Barco N.V. | 2017-12-21 |
| FilmArray Respiratory Panel 2 plus (RP2plus) (DEN170017) | Biofire Diagnostics, LLC | 2017-11-24 |
| MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay (DEN170058) | Memorial Sloan-Kettering Cancer Center | 2017-11-15 |
| Philips IntelliSite Pathology Solution (K172174) | Philips Medical Systems Nederland B.V. | 2017-10-04 |
| Philips IntelliSite Pathology Solution (DEN160056) | Philips Medical Systems Nederland B.V. | 2017-04-12 |
| CINtec Histology (50 tests), CINtec Histology (250 tests) (DEN160019) | Ventana Medical Systems, Inc. | 2017-03-04 |
| SASI-DC1TS (K970580) | Substance Abuse Specialties, Inc. | 1997-04-17 |
| INCSTAR HSZ I/II IGG ELISA ASSAY (K955363) | Incstar Corp. | 1996-07-24 |
| INCSTAR HSV I/II IGG FAST ELISA ASSAY (K955362) | Incstar Corp. | 1996-07-24 |
| SALINE SOLUTINE, STERILE (K950560) | Busse Hospital Disposables, Inc. | 1995-05-30 |
| CAPITOL URINE DRUG SCREEN COLLECTION KIT (K951122) | Harry A. Schlakman | 1995-05-05 |
| AD PERFECT (K940768) | Chimera Research & Chemical, Inc. | 1995-02-17 |
| DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS (K931474) | Gbf Medical Group | 1994-05-10 |
| PROFIBLOT (K933996) | Tecan U.S., Ltd. | 1994-01-28 |
| MICROWAVE AUTOMATED TISSUE PROCESSOR (K924590) | Innovative Medical Systems, Inc. | 1992-12-29 |
| DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM (K913967) | Doxtech, Inc. | 1991-10-18 |
| TRI-TECH URINE SPECIMEN KIT (K900983) | Tri-Tech, Inc. | 1990-09-17 |
| TISSUE EMBEDDING MEDIUM (K893772) | Stephens Scientific | 1989-06-22 |
| THE CEN-SLIDE(TM) CENTRIFUGE TUBE (K891604) | Davstar California, Inc. | 1989-06-16 |
| HEMAVIEW DARKFIELD MICROSCOPE SYSTEM (K885091) | Technalysis, Inc. | 1989-06-13 |
| LINISTAIN SLS (K890984) | Shandon, Inc. | 1989-04-04 |
| MICROSCOPE SLIDES PRECOATED (K890042) | Stat Path | 1989-01-13 |
| CONSED FECAL CONCENTRATION SYSTEM (K884755) | Donald L. Price, Ph.D. | 1989-01-10 |
| ATS MAYER'S ALBUMIN (K890022) | Alpha-Tec Systems, Inc. | 1989-01-10 |
| VERSABLOT (K884258) | American Bionetics, Inc. | 1988-12-14 |
| LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (K883599) | Innovative Medical Systems, Inc. | 1988-09-02 |
| EXAKT CUTTING & GRINDING SYSTEM (K883514) | Exakt Medical Instruments, Inc. | 1988-08-29 |
| ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (K883048) | Alpha-Tec Systems, Inc. | 1988-08-17 |
| ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID (K883062) | Alpha-Tec Systems, Inc. | 1988-08-04 |
| ZINC FORMALIN (K882874) | Anatech, Ltd. | 1988-07-28 |
| SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER (K882881) | Sakura Finetek U.S.A., Inc. | 1988-07-28 |
| SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR (K881165) | Sakura Finetek U.S.A., Inc. | 1988-07-01 |
| MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY (K882357) | Stat Path | 1988-06-16 |
| ZINC FORMALIN CONCENTRATE (K882268) | Anatech, Ltd. | 1988-06-15 |
| CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (K881922) | Surgipath Medical Industries, Inc. | 1988-05-25 |
| WESCOR MODEL 7300 AEROSPRAY GRAM STAINER (K881592) | Wescor, Inc. | 1988-05-13 |
| ATS PVA FIXATIVE SOLUTION (K881698) | Alpha-Tec Systems, Inc. | 1988-05-13 |
| LX-100 SLIDE STAINER (K880745) | Innovative Medical Systems, Inc. | 1988-04-27 |
| VIDEO ANALYZER 4000 (K874750) | Scientific Imaging, Inc. | 1988-04-25 |
| TISSUE SECTION ADHESIVE (K881659) | Surgipath Medical Industries, Inc. | 1988-04-21 |
| HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED (K881477) | Stat Path | 1988-04-18 |
| MICROSCOPE STAGE HEATER (K881467) | Cryodyne Technologies, Inc. | 1988-04-18 |