DeviceEstablishmentPulse / report

Siemens Medical Solutions USA, Inc. (manufacturer, Issaquah, WA): 7 new FDA device listings, incl. biopsy needle guide kit

Siemens Medical Solutions USA, Inc. (Issaquah, Washington): 7 new FDA device listings, incl. biopsy needle guide kit. Its amount of 7 is top-decile (90th percentile of 2,570 records). Dated 51 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 7 · 90th percentile of 2,570 DeviceEstablishmentPulse records · 7.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 9 related WA DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentSiemens Medical Solutions USA, Inc.
RoleManufacturer
Establishment typesComplaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
LocationIssaquah, WA, US
New listings7
DevicesBiopsy Needle Guide Kit; Automated Radiological Image Processing Software; System, Imaging, Pulsed Doppler, Ultrasonic; Catheter, Ultrasound, Intravascular; System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic
Product codesOIJ, QIH, IYN, OBJ, IYO, ITX
Device classesClass II
Medical specialtiesRadiology, Cardiovascular
Brand namesACUSON Origin ICE Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUNAV Luxera 4D ICE Catheter
First new listing2026-06-17
Latest new listing2026-09-14
FDA registration number3023245
Registration expires2027-12-31
amount percentile90th of 2,570 (median 1, 7.0x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-09-14
  • Data refreshed: 2026-10-28
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT

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Peer benchmark and outreach value: Siemens Medical Solutions USA, Inc. and 10 Washington peers

  • Washington DeviceEstablishmentPulse records like this one: 10
  • Siemens Medical Solutions USA, Inc.'s amount: 90th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Washington peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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85 / 100 Score

  • Brings its own devices to market: buys manufacturing, sterilization and QMS help.
  • Class II or III devices: QMS and regulatory demands.
  • Several new listings at once.
  • U.S. establishment.

What is the DeviceEstablishmentPulse record for Siemens Medical Solutions USA, Inc. in Issaquah, Washington?

Siemens Medical Solutions USA, Inc. (Issaquah, WA), a manufacturer, added 7 FDA device listings between 2026-06-17 and 2026-09-14.

How does Siemens Medical Solutions USA, Inc. compare to other Washington DeviceEstablishmentPulse records?

This is a top-decile record: its amount of 7 is 7.0x the median of 1 across 2,570 records. It is 51 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.

Siemens Medical Solutions USA, Inc. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Siemens Medical Solutions USA, Inc.Issaquah, WA790th2026-09-14
Abyrx, Inc.Stamford, CT790th2026-10-07
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA688th2026-10-16
Inquis Medical, Inc.Menlo Park, CA587th2026-10-16

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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.

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