510(k) Report

FDA applicant

Unirad Corp.

Mchenry, IL4 decisions1977–19800 recalls

FDA records 4 decisions for Unirad Corp. (Mchenry, IL) from 1977 to 1980: 4 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and HEM (Imager, Ultrasonic Obstetric-Gynecologic). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Unirad Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Unirad Corp.’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