FDA applicant
Sota Precision Optics, Inc. Dba Sota Imaging
FDA records 2 decisions for Sota Precision Optics, Inc. Dba Sota Imaging (Orange, CA) from 2020 to 2021: 2 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sota Precision Optics, Inc. Dba Sota Imaging’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Sota Precision Optics, Inc. Dba Sota…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Sota”
FDA records each applicant name separately; these may or may not be the same firm.