Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acoustic Imaging Technologies Corp. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923273 | AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM | Acoustic Imaging Technologies Corp. | 1994-12-27 | 904 | 0 |
| K924458 | AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ | Acoustic Imaging Technologies Corp. | 1993-01-21 | 141 | 0 |
| K910212 | COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST | Acoustic Imaging Technologies Corp. | 1991-07-11 | 177 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda