510(k) Report

FDA applicant

Intraop Medical, Inc.

Santa Clara, CA1 decision1998–19981 recall

FDA records 1 decision for Intraop Medical, Inc. (Santa Clara, CA) in 1998: 1 510(k) clearance. All are in product code LHN (System, Radiation Therapy, Charged-Particle…). Its devices cite 1 predicate, 0 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 Intraop Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intraop Medical, Inc. since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Intraop Medical, 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

Which product codes does it file in?

  • LHNSystem, Radiation Therapy, Charged-Particle, Medical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K981112MobetronIntraop Medical, Inc. · 19983cite it

What has FDA decided for it lately?

  • K981112MobetronIntraop Medical, Inc. · 19981 recall

The one decision as Intraop Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K981112Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers…Jun 20, 2008