IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR— 510(k) K041380
Substantially EquivalentR2 Technology, Inc.
FDA 510(k) clearance K041380 for IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR, Substantially Equivalent on 2004-06-08. Applicant: R2 Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- R2 Technology, Inc.
- Product code
- Code OEB
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code OEB
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