510(k) Report

FDA applicant

Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

Goleta, CA2 decisions2025–20260 recalls

FDA records 2 decisions for Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) (Goleta, CA) from 2025 to 2026: 2 510(k) clearances. Most are in product codes QFX (Diagnostic Neurosurgical Microscope Filter) and IZI (System, X-Ray, Angiographic). 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, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 12026 (partial year): 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QFXDiagnostic Neurosurgical Microscope Filter1decision
  • IZISystem, X-Ray, Angiographic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K251286Affirm 400Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · 2026
  • K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · 2025

All 2 as Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) →