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FDA device clearances in Washington

Every FDA 510(k) decision for applicants based in Washington in the last 12 months, with the device, the product area and FDA's own record.

Decisions25
Applicants11

25 premarket notifications (510(k)s) from applicants based in Washington were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.

DecidedApplicantDeviceAreaWhereRecord
2026-10-01FDC Technology Industry Co.Firstar Dental Electric Motor EBWDentalKent, WashingtonK260027
2026-10-01FDC Technology Industry Co.Firstar Dental Handpieces EFBDentalKent, WashingtonK260029
2026-09-25Philips Ultrasound, LLCEPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System IYNRadiologyBothell, WashingtonK262548
2026-09-10Siemens Medical Solutions USA, Inc.ACUNAV Luxera 4D ICE Catheter OBJCardiovascularIssaquah, WashingtonK261696
2026-08-04Philips Ultrasound, LLCAlturion Series Diagnostic Ultrasound System IYNRadiologyBothell, WashingtonK262311
2026-07-27Philips Ultrasound, LLCPhilips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System IYNRadiologyBothell, WashingtonK261211
2026-06-29Philips Ultrasound, LLCAlturion Series Diagnostic Ultrasound System IYNRadiologyBothell, WashingtonK260667
2026-06-26Cadwell Industries, Inc.Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array GXYNeurologyKennewick, WashingtonK261442
2026-06-16Siemens Medical Solutions USA, Inc.ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System IYNRadiologyIssaquah, WashingtonK260844
2026-05-27Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound System IYNRadiologyBothell, WashingtonK260123
2026-05-27Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems IYNRadiologyBothell, WashingtonK260680
2026-05-05Philips Ultrasound, LLCLumify Diagnostic Ultrasound System IYNRadiologyBothell, WashingtonK252558
2026-03-27Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System IYNRadiologyBothell, WashingtonK253595
2026-03-10FUJIFILM Sonosite, Inc.Sonosite iLOOK Ultrasound System IYNRadiologyBothell, WashingtonK260595
2026-02-13Measure Labs, Inc. (Dba Preemptiveai, Inc.)PreemptiveAI Clinical SDK DXHCardiovascularSeattle, WashingtonK250233
2026-01-30Precision Medical Ventures, Inc. Dba RevealdxRevealAI-Lung POKRadiologySeattle, WashingtonK251769
2026-01-16Solius Labs, Inc.SOLIUS PRO UVB Light Panel SGZGeneral, Plastic SurgeryBainbridge Island, WashingtonK252960
2026-01-07Amv Consulting, LLCSmileInspector PNNDentalBothell, WashingtonK252507
2025-12-22Philips Ultrasound, LLCLumify Diagnostic Ultrasound System IYNRadiologyBothell, WashingtonK252557
2025-12-15Proprio, Inc.Paradigm System OLONeurologySeattle, WashingtonK252950
2025-12-14Cadwell Industries, Inc.Hypnos (369054-200) OLZNeurologyKennewick, WashingtonK250851
2025-12-10Brainspace, Inc.Intellidrop JXGNeurologyBothell, WashingtonK251598
2025-11-17Siemens Medical Solutions USA, Inc.ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System IYNRadiologyIssaquah, WashingtonK253487
2025-11-13Siemens Medical Solutions USA, Inc.ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System IYNRadiologyIssaquah, WashingtonK253457
2025-11-03FUJIFILM Sonosite, Inc.Sonosite MT Ultrasound System IYNRadiologyBothell, WashingtonK253448

Where this comes from

Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.

A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.

All device clearances

Cite this page

Permanent URL: https://mentionfox.com/fda/510k/state/wa
Last updated 2026-10-18
FDA device clearances in Washington: 25 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/state/wa