Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shimadzu Precision Instruments, Inc. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
194 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940294 | SHIMADZU MOBILE X-RAY SYSTEMS | Shimadzu Precision Instruments, Inc. | 1994-03-16 | 54 | 0 |
| K890913 | SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT | Shimadzu Precision Instruments, Inc. | 1989-09-06 | 194 | 0 |
| K884598 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 | Shimadzu Precision Instruments, Inc. | 1989-04-20 | 168 | 0 |
| K884477 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B | Shimadzu Precision Instruments, Inc. | 1989-03-15 | 141 | 0 |
| K875378 | SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION | Shimadzu Precision Instruments, Inc. | 1988-11-16 | 321 | 0 |
| K882311 | SHIMADZU LATERAL C-ARM MH-31 | Shimadzu Precision Instruments, Inc. | 1988-09-14 | 103 | 0 |
| K881674 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC | Shimadzu Precision Instruments, Inc. | 1988-09-02 | 137 | 0 |
| K881795 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K | Shimadzu Precision Instruments, Inc. | 1988-07-01 | 65 | 0 |
| K874910 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 | Shimadzu Precision Instruments, Inc. | 1988-07-01 | 213 | 0 |
| K875370 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX | Shimadzu Precision Instruments, Inc. | 1988-05-18 | 139 | 0 |
| K874946 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 | Shimadzu Precision Instruments, Inc. | 1988-03-03 | 92 | 0 |
| K874767 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11 | Shimadzu Precision Instruments, Inc. | 1988-02-25 | 98 | 0 |
| K875372 | SHIMADZU CATHETERIZATION C-ARM STAND ER-200 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | 43 | 0 |
| K875376 | SHIMADZU CATHETERIZATION C-ARM STAND MH-50B | Shimadzu Precision Instruments, Inc. | 1988-02-12 | 43 | 0 |
| K875377 | SHIMADZU MAMMOGRAPHIC STAND MR-30 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | 43 | 0 |
| K875375 | SHIMADZU LATERAL C-ARM MH-30 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | 43 | 0 |
| K875380 | SHIMADZU CATHETERIZATION C-ARM STAND MH-10 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | 43 | 0 |
| K875373 | C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | 43 | 0 |
| K875374 | SHIMADZU CEILING-SUSPENDED C-ARM CH-50 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | 43 | 0 |
| K875379 | SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A | Shimadzu Precision Instruments, Inc. | 1988-02-12 | 43 | 0 |
| K875157 | SHIMADZU CATHETERIZATION C-ARM STAND MH-50A | Shimadzu Precision Instruments, Inc. | 1988-01-19 | 35 | 0 |
| K874639 | REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100 | Shimadzu Precision Instruments, Inc. | 1987-12-04 | 22 | 0 |
| K801957 | MICRO-FLOW SPECTROPHOTOMETER CL-720 | Shimadzu Precision Instruments, Inc. | 1980-09-26 | 39 | 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