Siemens Healthineers Ltd. (specification developer, SEONGNAM-SI Gyeonggi, KR): 6 new FDA device listings, incl. automated radiological image processing software
Siemens Healthineers Ltd. (SEONGNAM-SI Gyeonggi): 6 new FDA device listings, incl. automated radiological image processing software. Its amount of 6 is above the median of 2 (88th percentile). Dated 141 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-11-04, 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: 6 · 88th percentile of 2,709 DeviceEstablishmentPulse records · 3.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 121 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Siemens Healthineers Ltd. |
| Owner / operator | Siemens Medical Solutions USA, Inc. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | SEONGNAM-SI Gyeonggi, KR |
| New listings | 6 |
| Devices | Automated Radiological Image Processing Software; Biopsy Needle Guide Kit; Catheter, Ultrasound, Intravascular; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic |
| Product codes | QIH, OIJ, OBJ, IYN, IYO, ITX |
| Device classes | Class II |
| Medical specialties | Radiology, Cardiovascular |
| Brand names | ACUSON Origin ICE Diagnostic Ultrasound System; ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System |
| First new listing | 2026-06-17 |
| Latest new listing | 2026-06-17 |
| FDA registration number | 3002619337 |
| Registration expires | 2026-12-31 |
| amount percentile | 88th of 2,709 (median 2, 3.0x median) |
| Peer records CSV (122 KR records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-06-17
- Data refreshed: 2026-11-04
- 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, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Siemens Healthineers Ltd. and 122 KR peers
- KR DeviceEstablishmentPulse records like this one: 122
- Siemens Healthineers Ltd.'s amount: 88th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $24,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 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.
What is the DeviceEstablishmentPulse record for Siemens Healthineers Ltd. in SEONGNAM-SI Gyeonggi?
Siemens Healthineers Ltd. (SEONGNAM-SI Gyeonggi, KR), a specification developer (outsources manufacturing), added 6 FDA device listings on 2026-06-17.
How does Siemens Healthineers Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 6 sits in the upper half (88th percentile) of 2,709 records; the median is 2. It is 141 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Siemens Healthineers Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Siemens Healthineers Ltd. | SEONGNAM-SI Gyeonggi, KR | 6 | 88th | 2026-06-17 |
| Synthes (USA) Products LLC | West Chester, PA | 7 | 90th | 2026-10-23 |
| Deka Research & Development Corp. | Manchester, NH | 5 | 86th | 2026-10-19 |
| SHOULDER INNOVATIONS, Inc | Grand Rapids, MI | 7 | 90th | 2026-10-15 |
Related records
DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: Foreign establishment
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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.