Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Radionics Software Applications, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
398 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990326 | OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII | Radionics Software Applications, Inc. | 1999-03-04 | 30 | 0 |
| K974602 | OPTICAL TRACKING SYSTEM (OTS) | Radionics Software Applications, Inc. | 1998-04-21 | 133 | 0 |
| K972905 | XPLAN-1 | Radionics Software Applications, Inc. | 1997-10-28 | 83 | 0 |
| K964801 | OPTICAL TRACKING SYSTEM (OTS) | Radionics Software Applications, Inc. | 1997-06-02 | 185 | 0 |
| K961844 | OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] | Radionics Software Applications, Inc. | 1996-10-23 | 163 | 0 |
| K962155 | GILL-THOMAS-COSMAN(GTC) DENTAL TRAY | Radionics Software Applications, Inc. | 1996-08-22 | 79 | 0 |
| K960071 | IMAGEFUSION | Radionics Software Applications, Inc. | 1996-04-17 | 103 | 0 |
| K951262 | OPERATING ARM SYSTEM (OAS) | Radionics Software Applications, Inc. | 1995-11-13 | 237 | 0 |
| K944463 | CRW-1 SYSTEM | Radionics Software Applications, Inc. | 1995-10-26 | 409 | 4 |
| K953482 | XKNIFE-3 | Radionics Software Applications, Inc. | 1995-10-25 | 93 | 0 |
| K946252 | STEREOPLAN | Radionics Software Applications, Inc. | 1995-03-14 | 81 | 0 |
| K923522 | LINAC-BASED STEROTACTIC RADIOSURGERY | Radionics Software Applications, Inc. | 1993-08-18 | 398 | 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