Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imaging Dynamics Company , Ltd. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
167 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173273 | Aquarius 8600 1417WCI; Aquarius 8600 1717WCI | Imaging Dynamics Company , Ltd. | 2017-11-09 | 28 | 0 |
| K171169 | Aquarius 8600 1417TG and Aquarius 8600 1717TG | Imaging Dynamics Company , Ltd. | 2017-10-12 | 174 | 0 |
| K171175 | Aquarius 8600 1417WC | Imaging Dynamics Company , Ltd. | 2017-10-05 | 167 | 0 |
| K170202 | Aquarius 8600 | Imaging Dynamics Company , Ltd. | 2017-02-22 | 30 | 0 |
| K111098 | INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN | Imaging Dynamics Company , Ltd. | 2011-05-27 | 37 | 0 |
| K071401 | X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM | Imaging Dynamics Company , Ltd. | 2007-06-22 | 32 | 0 |
| K071408 | X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECT | Imaging Dynamics Company , Ltd. | 2007-06-13 | 23 | 0 |
| K071403 | X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM | Imaging Dynamics Company , Ltd. | 2007-06-11 | 21 | 0 |
| K071409 | X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM | Imaging Dynamics Company , Ltd. | 2007-06-08 | 18 | 0 |
| K071402 | X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM | Imaging Dynamics Company , Ltd. | 2007-06-08 | 18 | 0 |
| K070079 | X3C DIGITAL RADIOGRAPHIC DETECTOR | Imaging Dynamics Company , Ltd. | 2007-01-31 | 22 | 0 |
| K063247 | XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAN | Imaging Dynamics Company , Ltd. | 2006-11-22 | 27 | 0 |
| K063246 | XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND | Imaging Dynamics Company , Ltd. | 2006-11-22 | 27 | 0 |
| K063039 | XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM | Imaging Dynamics Company , Ltd. | 2006-11-02 | 30 | 0 |
| K062634 | ORTHOXP | Imaging Dynamics Company , Ltd. | 2006-10-06 | 30 | 0 |
| K062586 | XPLORER 1600 PLUS | Imaging Dynamics Company , Ltd. | 2006-09-29 | 28 | 0 |
| K062417 | XPLORER 1100 | Imaging Dynamics Company , Ltd. | 2006-09-15 | 28 | 0 |
| K062405 | XPLORER 1590 | Imaging Dynamics Company , Ltd. | 2006-09-13 | 29 | 0 |
| K061595 | XAMINER | Imaging Dynamics Company , Ltd. | 2006-08-17 | 70 | 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