S-scan MSK (Model 100001)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- S-scan MSK EUDAMED
- Model / Reference
- 100001 EUDAMED100001810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304455277 EUDAMED
- Basic UDI-DI
- 805630445ESA.MR0000003.Q2 EUDAMED
- EMDN Code
- Z11050101 SECTORAL TOMOGRAPHS (FOR TOMOGRAPHIC EXAMINATIONS OF THE EXTREMITIES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The S-scan MSK is a Class IIa musculoskeletal MRI system (Nomenclature Code: Z11050101) designed for high-resolution imaging of soft tissues and joints. It integrates dedicated musculoskeletal sequences, advanced radiofrequency coils, and proprietary computing technology to optimize diagnostic clarity for conditions such as ligament tears, tendon disorders, and articular cartilage defects.
This non-sterile, non-reusable device is supplied as a standalone MRI scanner (Reference: 100001810) and is authorized under FDA 510K and MDR regulations. It is intended for use in clinical settings with appropriate electromagnetic shielding, requiring no reprocessing or sterilization. The system supports full-body musculoskeletal imaging from extremities to spine, with UDI identifiers (e.g., 805630445ESA.MR0000003.Q2) for traceability.
Frequently asked questions
What types of musculoskeletal conditions can the S-scan MSK MRI system help diagnose with its specialized features?
The S-scan MSK is specifically designed for high-resolution imaging of soft tissues and joints, making it particularly useful for diagnosing conditions like ligament tears, tendon disorders, and articular cartilage defects. Its dedicated musculoskeletal sequences and advanced radiofrequency coils enhance diagnostic clarity for these areas, ensuring detailed visualization of soft tissue structures.
Is the S-scan MSK MRI system reusable or does it require sterilization between uses?
The S-scan MSK is a non-reusable, non-sterile device. Since it is a standalone MRI scanner, it does not require reprocessing or sterilization between uses, simplifying its maintenance and reducing operational complexity in clinical settings.
How is the S-scan MSK MRI system supplied, and what reference number should be used for ordering?
The S-scan MSK is supplied as a standalone MRI scanner. The reference number for ordering this device is 100001810, which corresponds to the Device Model 100001. This ensures traceability and proper identification when procuring the system.
Does the S-scan MSK MRI system require any special environmental conditions, such as electromagnetic shielding, for safe operation?
Yes, the S-scan MSK is intended for use in clinical settings with appropriate electromagnetic shielding. This is a standard requirement for MRI systems to ensure safe operation and prevent interference with other medical equipment or diagnostic accuracy.
What regulatory pathways does the S-scan MSK MRI system follow, and how can I verify its compliance?
The S-scan MSK is authorized under FDA 510K and MDR (Medical Device Regulation) pathways. Its compliance can be verified through the provided Basic UDI (805630445ESA.MR0000003.Q2) and UDI-DI Data (01HQ7XZN3DTYBBCEEECRNM69BC), which ensure traceability and regulatory adherence.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: S-scan: musculoskeletal MRI system for MSK professionals - Esaote, S-Scan - MSK Imaging, PDF The Next Step in Office MRI - esaote.com, Esaote S-scan MRI Systems - medical-xprt.com
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131996 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K151668 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K161238 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K121650 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.MR0000003.Q2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (2)
- EUDAMED aaff78c9-60c3-455b-8f8d-3804ccd53cc3 61 fields · synced Sep 18, 2026
- FDA 510(k) K131996 1 fields · synced May 18, 2026