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Sign in to claim this brandSCANMED, LLC
United States·US-MF-000011107
Last updated September 17, 2026
What SCANMED, LLC makes
ScanMed, LLC manufactures radio-frequency MRI system coils. Their product portfolio includes specialized imaging components such as elbow, knee, foot, blanket, and long bone coils, as well as pediatric head and spine arrays.
These medical devices are categorized as Class II and Class IIa products. The company is based in the United States, and their devices are listed in the FDA 510(k), FDA UDI, and EUDAMED regulatory databases.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does ScanMed, LLC primarily manufacture?
ScanMed, LLC specializes in manufacturing radio-frequency MRI system coils. These coils are designed to enhance imaging quality for specific body parts, including elbows, knees, feet, long bones, and pediatric head and spine regions. The company’s focus is on improving MRI diagnostic accuracy through specialized imaging components.
Where is ScanMed, LLC based, and what regulatory databases list its devices?
ScanMed, LLC is headquartered in the United States. Its devices are listed in key regulatory databases, including the FDA’s 510(k) and UDI registries, as well as EUDAMED in the European Union. These listings reflect compliance tracking for devices authorized in their respective markets.
How are ScanMed’s MRI coils classified under medical device regulations?
ScanMed’s MRI coils fall under Class II and Class IIa classifications. These classifications are determined by regulatory authorities based on factors like risk level and intended use. Class II devices typically require special controls beyond general controls to ensure safety and effectiveness, while Class IIa represents a subset with slightly lower risk.
Why are ScanMed’s coils listed in both FDA and EUDAMED databases?
ScanMed’s coils are listed in both the FDA’s U.S. regulatory systems and EUDAMED because they are designed for use in markets where these databases are mandatory for tracking medical devices. The FDA’s UDI and 510(k) listings apply to U.S. authorization, while EUDAMED is required for devices placed on the European market, ensuring transparency and compliance across regions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 9840, SOUTH 140 ST, Omaha, United States
- Website
- www.scanmed.com
- —
- —
- [email protected]
- Phone
- 1-402-934-2650
- PRRC Contact
- CARLEE SEEBA
- EUDAMED SRN
- US-MF-000011107
- FDA FEI Number
- 1000158431
- DUNS Number
- 080151631
Catalogue (47)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ScanMed Elbow Coil | 316GE1501 | FDA UDI | Class II | Active |
| ScanMed Knee/Foot Coil | 116GE1501 | FDA UDI | Class II | Active |
| ScanMed Blanket Coil | 516GE3001 | FDA UDI | Class II | Active |
| ScanMed Long Bone (M) Coil | 168GE3001 | FDA UDI | Class II | Active |
| ScanMed Elbow Coil | 308GE3001 | FDA UDI | Class II | Active |
| ScanMed Blanket Coil | 516PH3001 | FDA UDI | Class II | Active |
| ScanMed Long Bone (L) Coil | 169GE3001 | FDA UDI | Class II | Active |
| ScanMed PROCURE™ Coil | 508PH3001 | FDA UDI | Class II | Active |
| ScanMed Elbow Coil | 308GE1500 | FDA UDI | Class II | Active |
| ScanMed Blanket Coil | 516SI1501 | FDA UDI | Class II | Active |
| GEHC 1.5T Pediatric Head and Spine Array | E8800DA | FDA UDI | Class II | Active |
| ScanMed PROCURE™ Coil | 508SI1501 | FDA UDI | Class II | Active |
| ScanMed Elbow Coil | 308GE1501 | FDA UDI | Class II | Active |
| ScanMed Shoulder/Knee (M) Coil | 208GE3001 | FDA UDI | Class II | Active |
| ScanMed PROCURE™ Coil | 588GE1501 | FDA UDI | Class II | Active |
| ScanMed Shoulder/Knee (M) Coil | 208SI3001 | FDA UDI | Class II | Active |
| ScanMed Knee/Foot Coil | 108SI1501 | FDA UDI | Class II | Active |
| GEHC 1.5T Adult Head and Spine Array | E8800HS | FDA UDI | Class II | Active |
| ScanMed Long Bone (M) Coil | 168GE1501 | FDA UDI | Class II | Active |
| ScanMed Shoulder/Knee (M) Coil | 208SI1501 | FDA UDI | Class II | Active |
| ScanMed Blanket Coil | 516SI3001 | FDA UDI | Class II | Active |
| ScanMed Knee/Foot Coil | 116SI1501 | FDA UDI | Class II | Active |
| ScanMed PROCURE™ Coil | 508GE1501 | FDA UDI | Class II | Active |
| ScanMed PROCURE™ Coil | 508SI3001 | FDA UDI | Class II | Active |
| Philips ST SENSE NV 8 NeuroVascular Coil | 4535-303-62942 | FDA UDI | Class II | Active |
| ScanMed Knee/Foot Coil | 108SI3001 | FDA UDI | Class II | Active |
| ScanMed PROCURE™ Coil | 588PH1501 | FDA UDI | Class II | Active |
| ScanMed High Resolution Wrist Coil | 318SI3001 | FDA UDI | Class II | Active |
| ScanMed Elbow Coil | 308SI1501 | FDA UDI | Class II | Active |
| ScanMed PROCURE™ Coil | 508PH1501 | FDA UDI | Class II | Active |
| ScanMed Blanket Coil | 516GE1501 | FDA UDI | Class II | Active |
| ScanMed PROCURE™ Coil | 588GE3001 | FDA UDI | Class II | Active |
| ScanMed Shoulder/Knee (M) Coil | 208GE1501 | FDA UDI | Class II | Active |
| ScanMed Elbow Coil | 308SI3001 | FDA UDI | Class II | Active |
| ScanMed Knee/Foot Coil | 108GE3001 | FDA UDI | Class II | Active |
| ScanMed Hand/Wrist Coil | 316SI1501 | FDA UDI | Class II | Active |
| ScanMed Orbit and Mandible Coil | 994SI1501 | FDA UDI | Class II | Active |
| ScanMed PROCURE™ Coil | 508GE3001 | FDA UDI | Class II | Active |
| ScanMed Knee/Foot Coil | 116SI3001 | FDA UDI | Class II | Active |
| ScanMed Knee/Foot Coil | 108GE1501 | FDA UDI | Class II | Active |
| ScanMed PROCURE™ Coil | 588PH3001 | FDA UDI | Class II | Active |
| ScanMed Ankle Coil | 118SI3001 | FDA UDI | Class II | Active |
| ScanMed Knee/Foot Coil | 116GE3001 | FDA UDI | Class II | Active |
| ScanMed Long Bone (L) Coil | 169GE1501 | FDA UDI | Class II | Active |
| ProstatID | K212783 | FDA 510(k) | Class II | Active |
| Procure | 588SI3001 | EUDAMEDFDA UDI | Class IIa | Active |
| Procure | 588SI1501 | EUDAMEDFDA UDI | Class IIa | Active |
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