Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Invivo Corporation (Business Trade Name: Philips) · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
255 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232762 | dS Breast Coil 7ch 1.5T | Invivo Corporation (Business Trade Name: Philips) | 2023-10-03 | 25 | 0 |
| K222325 | 8ch Wrist Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-31 | 29 | 0 |
| K222257 | 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-23 | 27 | 0 |
| K213727 | dS Sentinelle Breast 16ch 3.0T Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-08 | 255 | 0 |
| K213735 | dS Sentinelle Breast 16ch 1.5T Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-08 | 252 | 0 |
| K213351 | ds Head 32ch 3.0T | Invivo Corporation (Business Trade Name: Philips) | 2021-10-29 | 21 | 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