AIRS Medical Inc. (manufacturer, Seoul, KR): 4 new FDA device listings, incl. automated radiological image processing software
AIRS Medical Inc. (Seoul): 4 new FDA device listings, incl. automated radiological image processing software. Its amount of 4 is above the median of 2 (83rd percentile). Dated 23 days ago, it is in the active follow-up window. Score 85/100. 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: 4 · 83th percentile of 2,709 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 121 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | AIRS Medical Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198 |
| Location | Seoul, KR |
| New listings | 4 |
| Devices | Automated Radiological Image Processing Software; System, Nuclear Magnetic Resonance Imaging; System, Digital Image Communications, Radiological |
| Product codes | QIH, LNH, LMD |
| Device classes | Class I, Class II |
| Medical specialties | Radiology |
| Brand names | SwiftMR(A20-CL/A22-OP); SwiftSight-BodyComposition; SwiftSight-Hub |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-10-13 |
| FDA registration number | 3024820186 |
| Registration expires | 2027-12-31 |
| amount percentile | 83th of 2,709 (median 2, 2.0x 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: 2026-10-13
- 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: AIRS Medical Inc. and 122 KR peers
- KR DeviceEstablishmentPulse records like this one: 122
- AIRS Medical Inc.'s amount: 83rd percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every KR peer: $24,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
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.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for AIRS Medical Inc. in Seoul?
AIRS Medical Inc. (Seoul, KR), a manufacturer, added 4 FDA device listings between 2026-06-01 and 2026-10-13.
How does AIRS Medical Inc. compare to other DeviceEstablishmentPulse records?
Its amount of 4 sits in the upper half (83th percentile) of 2,709 records; the median is 2. It is 23 days old, still within a typical 45-day follow-up window. Its Score of 85/100 puts it among the stronger signals in this feed.
AIRS Medical Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| AIRS Medical Inc. | Seoul, KR | 4 | 83rd | 2026-10-13 |
| Applied Medical Resources Corp. | Rsm, CA | 3 | 77th | 2026-10-23 |
| Inter-Med, Inc. | Racine, WI | 5 | 86th | 2026-10-22 |
| Centerpoint Systems LLC | West Valley City, UT | 5 | 86th | 2026-10-21 |
Related records
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- Inter-Med, Inc.
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- Biomerieux, Inc.
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- Masimo Corporation
- Centerpoint Systems LLC
- Tornier, Inc.
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- Coopersurgical, Inc.
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DeviceEstablishmentPulse: 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.