OmniTom— 510(k) K171183
Substantially EquivalentNeurologica Corporation
FDA 510(k) clearance K171183 for OmniTom, Substantially Equivalent on 2017-08-18. Applicant: Neurologica Corporation. Device class: 2.
Clearance details
- Applicant
- Neurologica Corporation
- 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
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 K171183
K-number listed on FDA's recall record- Z-2068-2023 — OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000
- Z-2772-2020 — OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171183.
Data sourced from openFDA. This site is unofficial and independent of the FDA.