Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Panasonic Healthcare Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K122009 | AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCE | Panasonic Healthcare Co., Ltd. | 2012-10-03 | 86 | 0 |
| K113612 | AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A | Panasonic Healthcare Co., Ltd. | 2012-02-10 | 66 | 0 |
| K103148 | AIDA DIAGNOSTIC ULTRASOUND SYSTEM | Panasonic Healthcare Co., Ltd. | 2011-03-11 | 137 | 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