FDA applicant
Exact Imaging, Inc.
FDA records 4 decisions for Exact Imaging, Inc. (Markham, CA) from 2016 to 2019: 4 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 39 days from receipt to decision, against 68 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Exact Imaging”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Exact Imaging, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Exact Imaging, 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) ReportOther applicant names beginning “Exact”
FDA records each applicant name separately; these may or may not be the same firm.