Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Konica Minolta Medical & Graphic, Inc. · Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
171 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130936 | AERODR SYSTEM WITH P-31 | Konica Minolta Medical & Graphic, Inc. | 2013-08-22 | 140 | 0 |
| K123499 | AEROPILOT | Konica Minolta Medical & Graphic, Inc. | 2012-12-20 | 37 | 0 |
| K120752 | AERODR STITCHING SYSTEM | Konica Minolta Medical & Graphic, Inc. | 2012-06-08 | 88 | 0 |
| K121109 | AERODR X70 | Konica Minolta Medical & Graphic, Inc. | 2012-05-23 | 41 | 0 |
| K120477 | AEROSYNC FOR AERODR SYSTEM | Konica Minolta Medical & Graphic, Inc. | 2012-04-09 | 53 | 0 |
| K120131 | REGIUS SIGMA2 | Konica Minolta Medical & Graphic, Inc. | 2012-02-10 | 24 | 0 |
| K113248 | AERODR SYSTEM WITH P-21 | Konica Minolta Medical & Graphic, Inc. | 2012-01-17 | 75 | 0 |
| K110717 | KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM | Konica Minolta Medical & Graphic, Inc. | 2011-12-23 | 283 | 0 |
| K103703 | REGUIS SIGMA | Konica Minolta Medical & Graphic, Inc. | 2011-06-02 | 164 | 0 |
| K101842 | ACIES | Konica Minolta Medical & Graphic, Inc. | 2011-02-04 | 218 | 0 |
| K102349 | AERODR SYSTEM | Konica Minolta Medical & Graphic, Inc. | 2010-11-24 | 97 | 0 |
| K092717 | DIRECT DIGITIZER, REGIUS MODEL 210 | Konica Minolta Medical & Graphic, Inc. | 2009-10-30 | 57 | 0 |
| K081637 | LASER IMAGER DRYPRO MODEL 873 | Konica Minolta Medical & Graphic, Inc. | 2008-07-01 | 20 | 0 |
| K071436 | REGIUS UNITEA | Konica Minolta Medical & Graphic, Inc. | 2007-06-27 | 35 | 0 |
| K071181 | DIRECT DIGITIZER, REGIUS MODEL 110 | Konica Minolta Medical & Graphic, Inc. | 2007-05-30 | 30 | 0 |
| K061999 | DRY LASER IMAGER, DRYPRO MODEL 832 | Konica Minolta Medical & Graphic, Inc. | 2006-08-15 | 32 | 0 |
| K053173 | DS CASSETTE | Konica Minolta Medical & Graphic, Inc. | 2005-12-15 | 31 | 0 |
| K051998 | REGIUS MODEL 170 DIRECT DIGITIZER | Konica Minolta Medical & Graphic, Inc. | 2005-11-03 | 101 | 0 |
| K052095 | MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 | Konica Minolta Medical & Graphic, Inc. | 2005-11-03 | 101 | 0 |
| K051523 | REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL I | Konica Minolta Medical & Graphic, Inc. | 2005-07-20 | 42 | 1 |
| K051418 | DIRECT DIGITIZER REGIUS MODEL 370 | Konica Minolta Medical & Graphic, Inc. | 2005-07-01 | 30 | 1 |
| K051521 | REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION | Konica Minolta Medical & Graphic, Inc. | 2005-06-28 | 20 | 0 |
| K042386 | DIRECT DIGITIZER, REGIUS MODEL 190 | Konica Minolta Medical & Graphic, Inc. | 2004-12-15 | 104 | 0 |
| K042133 | DRY LASER IMAGER, MODEL DRYPRO MODEL 793 | Konica Minolta Medical & Graphic, Inc. | 2004-11-24 | 107 | 0 |
| K023061 | KONICA DIRECT DIGITIZER REGIUS, MODEL 170 | Konica Minolta Medical & Graphic, Inc. | 2002-10-11 | 25 | 0 |
| K013054 | KONICA DIRECT DIGITIZER REGIUS MODEL 350 | Konica Minolta Medical & Graphic, Inc. | 2002-03-01 | 171 | 0 |
| K013052 | KONICA LASER IMAGER, DRYPRO MODEL 751/752 | Konica Minolta Medical & Graphic, Inc. | 2002-01-16 | 127 | 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