0180 INTUITION, 0072 PRECISION— 510(k) K140683
Substantially EquivalentArcoma AB
FDA 510(k) clearance K140683 for 0180 INTUITION, 0072 PRECISION, Substantially Equivalent on 2014-06-03. Applicant: Arcoma AB. Device class: 2.
Clearance details
- Applicant
- Arcoma AB
- 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
- Special
- Location
- Naples, FL, US
Recent devices under product code KPR
view allMore clearances from Arcoma AB
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 K140683
K-number listed on FDA's recall record- Z-1331-2022 — Omnera 400T Digital Radiographic System
- Z-1332-2022 — Omnera 400A Digital Radiographic System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140683.
Data sourced from openFDA. This site is unofficial and independent of the FDA.