Iray Korea Limited (contract manufacturer, Seoul, KR): 1 new FDA device listing, incl. solid state x-ray imager (flat panel/digital imager)
Iray Korea Limited (Seoul): 1 new FDA device listing, incl. solid state x-ray imager (flat panel/digital imager). Its amount of 1 is above the median of 1 (50th percentile). Dated 64 days ago, it serves as a historical benchmark. Score 55/100. 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: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 116 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Iray Korea Limited |
| Owner / operator | iRay Korea Limited |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Seoul, KR |
| New listings | 1 |
| Devices | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Product codes | MQB |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | Lux HD 2530 |
| First new listing | 2026-09-02 |
| Latest new listing | 2026-09-02 |
| FDA registration number | 3015464948 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (117 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: 2026-09-02
- 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: Iray Korea Limited and 117 KR peers
- KR DeviceEstablishmentPulse records like this one: 117
- Iray Korea Limited's amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $23,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for Iray Korea Limited in Seoul?
Iray Korea Limited (Seoul, KR), a contract manufacturer, added 1 FDA device listing on 2026-09-02.
How does Iray Korea Limited compare to other DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 64 days old; check the official source for later updates before acting.
Iray Korea Limited vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Iray Korea Limited | Seoul, KR | 1 | 50th | 2026-09-02 |
| Tecomet Inc. | Wilmington, MA | 3 | 77th | 2026-10-15 |
| Bard Shannon Limited | Humacao, PR | 3 | 77th | 2026-10-14 |
| Orchid Orthopedic Solutions Oregon, Inc. | Oregon City, OR | 3 | 77th | 2026-10-05 |
Related records
DeviceEstablishmentPulse: Contract manufacturer 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.