Compliance
Regulatory status, stated accurately.
For a medical device, the certification page is the first thing a procurement team checks — and the easiest place to destroy trust. Status is stated exactly as it is, including pending applications.
Regulatory
Clearances by market.
Availability and cleared configurations vary by market. The current status for your region is confirmed in writing on request.
| Certification | Region | Scope | Status |
|---|---|---|---|
| FDA 510(k) | United States | Magnetic resonance imaging system — K243884 | Cleared |
| NMPA registration | China | ARMOUR Formula III — 国械注准20243061504 | Registered |
| CE / MDR | European Union | Magnetic resonance imaging system — Formula I | Certified |
| IECEE CB | International | Magnetic resonance imaging system — ARMOUR I | Active |
| IAC accreditation | United States | Musculoskeletal MRI — Alpha Orthopedic Physician Group | Active through 2027-07-31 |
| ISO 13485 | International | Quality management system | Stated on request |
Swipe the table sideways to see the scope and status columns.
Documents
Certificates.
Scanned certificates, where publication is permitted.
IMAGE PLACEHOLDERISO 13485 — available on request4 × 3
Quality
How the systems are built.
Quality management
Documented processes covering design, production and post-market surveillance.
Testing & verification
Acceptance testing on every system before shipment.
Traceability
Component and software version records per unit.
Need the paperwork for a tender?
Tell us the market and the submission deadline and we will confirm exactly what can be provided.