Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shimadzu Corp. — Predicate Candidate Screening
49 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
248 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142341 | X-RAY TV SYSTEM SONIALVISION G4 | Shimadzu Corp. | 2015-03-06 | 197 | 0 |
| K131075 | X-RAY TV SYSTEM SONIAL VISION G4 | Shimadzu Corp. | 2014-03-28 | 345 | 0 |
| K101039 | SHIMADZU COLLIMATOR R-300 | Shimadzu Corp. | 2010-09-20 | 159 | 0 |
| K101036 | SHIMADZU COLLIMATOR R-20J | Shimadzu Corp. | 2010-08-26 | 134 | 1 |
| K090578 | SHIMADZU COLLIMATOR R-30H | Shimadzu Corp. | 2009-11-06 | 248 | 1 |
| K090268 | SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION | Shimadzu Corp. | 2009-06-30 | 147 | 1 |
| K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION | Shimadzu Corp. | 2008-05-14 | 64 | 2 |
| K072006 | DAR-9400F | Shimadzu Corp. | 2007-08-31 | 39 | 0 |
| K071717 | GE OEC ALTITUDE | Shimadzu Corp. | 2007-07-05 | 13 | 0 |
| K062360 | BRANSIST SAFIRE | Shimadzu Corp. | 2006-10-05 | 52 | 1 |
| K050925 | DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE | Shimadzu Corp. | 2005-06-01 | 49 | 0 |
| K043379 | SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL W | Shimadzu Corp. | 2005-02-17 | 71 | 0 |
| K042840 | SHIMADZU COLLIMATOR R-20J | Shimadzu Corp. | 2004-12-03 | 50 | 0 |
| K041763 | SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES | Shimadzu Corp. | 2004-07-13 | 13 | 1 |
| K040870 | SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS | Shimadzu Corp. | 2004-05-17 | 45 | 0 |
| K032443 | DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE | Shimadzu Corp. | 2004-02-20 | 196 | 0 |
| K033184 | LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 | Shimadzu Corp. | 2003-12-09 | 69 | 0 |
| K031771 | SHIMADZU COLLIMATOR R-30H | Shimadzu Corp. | 2003-08-21 | 73 | 0 |
| K012424 | SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM | Shimadzu Corp. | 2001-10-18 | 80 | 0 |
| K011141 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-78 | Shimadzu Corp. | 2001-07-03 | 81 | 0 |
| K001517 | SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES | Shimadzu Corp. | 2000-06-27 | 42 | 2 |
| K991553 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-70 | Shimadzu Corp. | 1999-06-08 | 36 | 0 |
| K990715 | SHIMADZU CEILING TUBE SUPPORT CH-30GH | Shimadzu Corp. | 1999-04-16 | 43 | 0 |
| K982583 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-68 | Shimadzu Corp. | 1998-10-05 | 73 | 0 |
| K973342 | DAR-3000B | Shimadzu Corp. | 1997-10-08 | 33 | 0 |
| K955036 | MOBILE X-RAY SYSTEM | Shimadzu Corp. | 1995-12-22 | 49 | 0 |
| K952822 | SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G | Shimadzu Corp. | 1995-07-12 | 22 | 0 |
| K945389 | IVR MASTER | Shimadzu Corp. | 1995-02-07 | 96 | 0 |
| K945388 | DFS-700 | Shimadzu Corp. | 1995-01-30 | 88 | 0 |
| K942731 | SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR | Shimadzu Corp. | 1994-10-13 | 147 | 0 |
| K942792 | BUCKY STAND BR-10M | Shimadzu Corp. | 1994-07-29 | 45 | 0 |
| K935487 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF | Shimadzu Corp. | 1994-07-05 | 232 | 0 |
| K933472 | SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIES | Shimadzu Corp. | 1994-02-07 | 207 | 0 |
| K934967 | SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR | Shimadzu Corp. | 1993-12-13 | 59 | 0 |
| K934005 | SHIMADZU CEILING TUBE SUPPORT CH-30GX | Shimadzu Corp. | 1993-11-24 | 98 | 0 |
| K933471 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G | Shimadzu Corp. | 1993-11-24 | 132 | 0 |
| K933473 | CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM | Shimadzu Corp. | 1993-11-24 | 132 | 0 |
| K897073 | ADDITIONAL TRANSDUCERS FOR USE W/SDL 300 | Shimadzu Corp. | 1990-08-21 | 242 | 0 |
| K896644 | ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500 | Shimadzu Corp. | 1990-08-21 | 270 | 0 |
| K896999 | SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENT | Shimadzu Corp. | 1990-08-09 | 239 | 0 |
| K895394 | MOBILE X-RAY TELEVISION UNIT WHA-10A/B | Shimadzu Corp. | 1989-11-13 | 68 | 0 |
| K875187 | SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT | Shimadzu Corp. | 1988-12-12 | 356 | 0 |
| K873674 | SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER | Shimadzu Corp. | 1988-10-07 | 392 | 0 |
| K854337 | SDL-300 | Shimadzu Corp. | 1986-06-20 | 235 | 0 |
| K850834 | SDL-32 ELECTRONIC LINEAR SCANNER | Shimadzu Corp. | 1985-10-31 | 244 | 0 |
| K834280 | SDL-30 | Shimadzu Corp. | 1984-04-25 | 163 | 0 |
| K840611 | DSL-150 | Shimadzu Corp. | 1984-04-20 | 67 | 0 |
| K837314 | SDL-10 DIAGNOSTIC ULTRASOUND | Shimadzu Corp. | 1983-04-29 | 38 | 0 |
| K791040 | SECTOR SCANNER, SDU-100, COMPUTERIZED | Shimadzu Corp. | 1979-10-04 | 121 | 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