ACCUSOFT, ACCUSOFT XL— 510(k) K062032
Substantially EquivalentDirex Systems Corp.
FDA 510(k) clearance K062032 for ACCUSOFT, ACCUSOFT XL, Substantially Equivalent on 2006-10-05. 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
- Canton, MA, US
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