FDA applicant

Xoft, Inc.

Sunnyvale, CA6 decisions2005–20091 recall

FDA records 6 decisions for Xoft, Inc. (Sunnyvale, CA) from 2005 to 2009: 6 510(k) clearances. Most are in product codes JAD (System, Therapeutic, X-Ray) and IXI (Block, Beam-Shaping, Radiation Therapy). Its devices cite 11 predicates, 2 of them its own earlier devices. 1 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, radiology panel, where it files most

How often FDA has decided Xoft, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2009

2007high 3 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Xoft, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xoft, Inc.’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) Report

Other applicant names beginning “Xoft”

FDA records each applicant name separately; these may or may not be the same firm.

Xoft, an Icad Company 1

Xoft, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Xoft”