Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgical Navigation Technologies, Inc. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
188 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000246 | RADIOCAMERAS EXTRACRANIAL SYSTEM | Surgical Navigation Technologies, Inc. | 2000-10-20 | 267 | 0 |
| K994355 | RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION | Surgical Navigation Technologies, Inc. | 2000-03-22 | 90 | 0 |
| K992461 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Surgical Navigation Technologies, Inc. | 2000-02-22 | 214 | 0 |
| K992927 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Surgical Navigation Technologies, Inc. | 1999-12-29 | 120 | 1 |
| K993021 | METRX SYSTEM | Surgical Navigation Technologies, Inc. | 1999-11-10 | 63 | 3 |
| K992354 | SNT IMAGE ANALYSIS SYSTEM | Surgical Navigation Technologies, Inc. | 1999-10-12 | 90 | 0 |
| K991468 | IMMERGE IMAGE CORRELATION | Surgical Navigation Technologies, Inc. | 1999-07-06 | 70 | 0 |
| K990214 | FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM | Surgical Navigation Technologies, Inc. | 1999-04-22 | 90 | 29 |
| K983670 | STEALTHSTATION SYSTEM | Surgical Navigation Technologies, Inc. | 1999-01-14 | 87 | 0 |
| K984000 | STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM | Surgical Navigation Technologies, Inc. | 1999-01-12 | 63 | 0 |
| K983397 | STEALTHSTATION TREATMENT GUIDANCE PLAFFORM | Surgical Navigation Technologies, Inc. | 1998-12-04 | 70 | 0 |
| K981768 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Surgical Navigation Technologies, Inc. | 1998-11-23 | 188 | 0 |
| K981686 | STEALTHSTATION SYSTEM DIGITIZER CHANGE | Surgical Navigation Technologies, Inc. | 1998-08-07 | 86 | 0 |
| K981684 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Surgical Navigation Technologies, Inc. | 1998-08-06 | 85 | 0 |
| K981346 | RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM | Surgical Navigation Technologies, Inc. | 1998-07-10 | 87 | 0 |
| K980750 | RADIOCAMERAS PATIENT POSITIONING SYSTEM | Surgical Navigation Technologies, Inc. | 1998-05-20 | 83 | 0 |
| K974187 | STEALTHSTATION SYSTEM | Surgical Navigation Technologies, Inc. | 1998-01-21 | 131 | 0 |
| K974161 | STEALTHSTATION SYSTEM | Surgical Navigation Technologies, Inc. | 1997-11-21 | 86 | 0 |
| K971893 | SNT LINAC ACCESSORIES | Surgical Navigation Technologies, Inc. | 1997-11-13 | 175 | 0 |
| K972398 | STEALTHSTATION PASSIVE INSTRUMENT OPTION | Surgical Navigation Technologies, Inc. | 1997-09-16 | 82 | 1 |
| K971675 | SNT STEREOTACTIC LOCALIZATION SYSTEM | Surgical Navigation Technologies, Inc. | 1997-07-14 | 68 | 0 |
| K971247 | SNT DISPOSABLE BIOPSY NEEDLE | Surgical Navigation Technologies, Inc. | 1997-06-16 | 74 | 2 |
| K970623 | IMMERGE IMAGE CORRELATION | Surgical Navigation Technologies, Inc. | 1997-04-28 | 68 | 0 |
| K964517 | LINAC SCALPEL FLOORSTAND | Surgical Navigation Technologies, Inc. | 1997-04-01 | 140 | 0 |
| K962792 | LINAC SCALPEL TREATMENT PLANNING SYSTEM | Surgical Navigation Technologies, Inc. | 1996-11-12 | 118 | 3 |
| K963173 | STEALTHSTATION SYSTEM | Surgical Navigation Technologies, Inc. | 1996-10-25 | 72 | 0 |
| K954276 | STEALTHSTATION | Surgical Navigation Technologies, Inc. | 1996-01-24 | 133 | 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