Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Philips Healthcare (Cleveland) · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
308 daysmedian FDA review time
362 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133674 | PHILIPS IQON SPECTRAL CT | Philips Healthcare (Cleveland) | 2014-11-21 | 357 | 0 |
| K131773 | BRILLIANCE ICT | Philips Healthcare (Cleveland) | 2013-09-24 | 99 | 0 |
| K123599 | INGENUITY DIGITAL PET/CT | Philips Healthcare (Cleveland) | 2013-07-12 | 233 | 1 |
| K123576 | IMR SOFTWARE APPLICATION | Philips Healthcare (Cleveland) | 2013-06-07 | 199 | 0 |
| K113483 | ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION | Philips Healthcare (Cleveland) | 2012-09-26 | 308 | 0 |
| K103483 | INGENUITY TF PET/MR | Philips Healthcare (Cleveland) | 2011-11-23 | 362 | 4 |
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