Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IXC — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
89 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991302 | SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000P | Smartlight, Inc. | 1999-06-01 | 46 | 0 |
| K973965 | SMART MOTORIZED VIEWER | Smartlight, Ltd. | 1997-12-12 | 56 | 0 |
| K973115 | ARRIPRO 35 ST/TV | Arnold & Richter Cine Technik | 1997-09-02 | 13 | 0 |
| K970240 | DIFFUSER PANEL | Focused Viewer, Inc. | 1997-03-11 | 48 | 0 |
| K954998 | LILY DARK VIEWER | Lily Imaging Solutions Co. | 1996-01-29 | 89 | 0 |
| K954199 | VOXBOX | Voxel | 1995-09-29 | 23 | 0 |
| K952188 | ADVIEWER 2000 | Adp , Ltd. | 1995-05-30 | 21 | 0 |
| K922848 | ULTRALITE X-RAY FILM ILLUMINATOR | A & S Trading Co. | 1992-09-28 | 102 | 0 |
| K922079 | ROTOLUX, SELECTOLUX, SHUTTERVUE | American Medical Sales, Inc. | 1992-06-16 | 43 | 0 |
| K883702 | EXCELVIEW ILLUMINATOR | Excel Medical Products, Inc. | 1988-09-19 | 20 | 0 |
| K875233 | VARIVIEWER (X-RAY FILM VIEWER) | Diversified Diagnostic Products, Inc. | 1988-01-19 | 28 | 0 |
| K872245 | PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM | General Electric Co. | 1987-06-19 | 8 | 0 |
| K854933 | SANDHILL ELECTRONIC CALIPER | Sandhill | 1986-02-12 | 64 | 0 |
| K840607 | LF MOTORIZED RADIOGRAPHIC FILM VIEWER | Sybron Corp. | 1984-03-05 | 21 | 0 |
| K812152 | MEDI VIEW | Medical Synergy | 1981-09-09 | 42 | 0 |
| K802217 | VIEW-LITE, MODEL-SL | Med-Western Electronics, Inc. | 1980-10-23 | 41 | 0 |
| K802216 | VIEW-LITE, MODEL-DL | Med-Western Electronics, Inc. | 1980-10-23 | 41 | 0 |
| K802215 | VIEW-LITE, MODEL-S | Med-Western Electronics, Inc. | 1980-10-23 | 41 | 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