ACCUSOFT— 510(k) K040474
Substantially EquivalentDirex Systems Corp.
FDA 510(k) clearance K040474 for ACCUSOFT, Substantially Equivalent on 2004-06-23. Applicant: Direx Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Direx Systems Corp.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Natick, MA, US
Recent devices under product code MUJ
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