OmniTom Elite— 510(k) K202526
Substantially EquivalentNeurologica Corporation, A Subsidiary of Samsung Electronics
FDA 510(k) clearance K202526 for OmniTom Elite, Substantially Equivalent on 2020-12-23. Applicant: Neurologica Corporation, A Subsidiary of Samsung Electronics. Device class: 2.
Clearance details
- Applicant
- Neurologica Corporation, A Subsidiary of Samsung Electronics
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
Recent devices under product code JAK
view allMore clearances from Neurologica Corporation, A Subsidiary of Samsung Electronics
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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 K202526
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 K202526.
Data sourced from openFDA. This site is unofficial and independent of the FDA.