Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Canon Inc. -Medical Equipment Group · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
158 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173689 | Ophthalmic Software Platform RX | Canon Inc. -Medical Equipment Group | 2018-02-23 | 84 | 0 |
| K162909 | CSX-30 Flat Panel Detector | Canon, Inc. – Medical Equipment Group | 2017-01-27 | 102 | 0 |
| K123208 | DIGITAL RETINAL CAMERA | Canon Inc. -Medical Equipment Group | 2013-03-19 | 158 | 0 |
| K121303 | MOBILE C-ARM | Canon Inc. -Medical Equipment Group | 2012-07-26 | 86 | 0 |
| K111824 | FLAT PANEL DETECTOR | Canon Inc. -Medical Equipment Group | 2012-04-23 | 300 | 0 |
| K111710 | FULL AUTO TONOMETER MODEL TX-20 | Canon Inc. -Medical Equipment Group | 2011-09-20 | 92 | 0 |
| K111682 | DIGITAL RADIOGRAPHY | Canon Inc. -Medical Equipment Group | 2011-09-02 | 79 | 0 |
| K112309 | DIGITAL RADIOGRAPHY | Canon Inc. -Medical Equipment Group | 2011-09-02 | 22 | 0 |
| K103591 | DIGITAL RADIOGRAPHY | Canon Inc. -Medical Equipment Group | 2011-03-29 | 112 | 0 |
| K102013 | DIGITAL RETINAL CAMERA | Canon Inc. -Medical Equipment Group | 2010-10-29 | 105 | 0 |
| K102012 | DIGITAL RADIOGRAPHY | Canon Inc. -Medical Equipment Group | 2010-08-17 | 32 | 1 |
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