OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM— 510(k) K012546
Substantially EquivalentSedecal USA, Inc.
FDA 510(k) clearance K012546 for OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM, Substantially Equivalent on 2001-11-02. Applicant: Sedecal USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Sedecal USA, Inc.
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deer Field, IL, US
Recent devices under product code KPR
view allMore clearances from Sedecal USA, Inc.
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K012546
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012546.
Data sourced from openFDA. This site is unofficial and independent of the FDA.