Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IXL · Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
53 daysmedian FDA review time
96 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111304 | OPTIMA XR120 | Ge Medical Systems, LLC | 2011-07-19 | 71 | 0 |
| K964806 | MD-1835 | Fischer Imaging Corp. | 1997-03-04 | 95 | 0 |
| K950317 | ADVANTX 1824 SPOTFILM DEVICE | GE Medical Systems | 1995-02-08 | 13 | 0 |
| K940386 | KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP | Eastman Kodak Company | 1994-08-17 | 203 | 0 |
| K942367 | AXT 1400 SPOTFILM DEVICE | Applied X-Ray Technologies, Inc. | 1994-06-06 | 19 | 0 |
| K924593 | DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 | Philips Medical Systems, Inc. | 1992-11-24 | 75 | 1 |
| K902403 | ELITE R/F SPOT FILM DRIVE | Rms Div. | 1990-08-01 | 62 | 0 |
| K902146 | SFD-035 SPOT FILM DEVICE | Rms Div. | 1990-05-31 | 17 | 0 |
| K882492 | A.X.T. SPOTFILM DEVICE | Applied X-Ray Technologies, Inc. | 1988-07-21 | 35 | 0 |
| K881589 | 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 | Continental X-Ray Corp. | 1988-07-18 | 96 | 0 |
| K842184 | SPOT-FILM DEVICE 8835 | General Electric Co. | 1984-07-17 | 46 | 0 |
| K802888 | RAYTHEON MEDICAL IMAGING | Machlett Laboratories, Inc. | 1981-01-09 | 53 | 0 |
| K800554 | MULTI-FORMAT SFD MODEL 1720 | Philips Medical Systems (Cleveland), Inc. | 1980-04-10 | 29 | 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