Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Instrumentarium Imaging, Inc. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
256 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002472 | DELTA 32 AND DELTA 32 TACT | Instrumentarium Imaging, Inc. | 2000-11-29 | 110 | 0 |
| K001928 | SIGMA | Instrumentarium Imaging, Inc. | 2000-08-02 | 37 | 0 |
| K000976 | DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) | Instrumentarium Imaging, Inc. | 2000-06-01 | 66 | 1 |
| K001171 | DELTA 16 TACT | Instrumentarium Imaging, Inc. | 2000-05-12 | 31 | 0 |
| K973642 | ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 | Instrumentarium Imaging, Inc. | 1997-11-21 | 58 | 0 |
| K955411 | DELTA 16 | Instrumentarium Imaging, Inc. | 1996-03-21 | 115 | 0 |
| K925987 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1993-05-19 | 175 | 0 |
| K924921 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1993-05-17 | 234 | 0 |
| K923581 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1993-05-03 | 287 | 0 |
| K924472 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1993-05-03 | 243 | 0 |
| K923352 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1992-10-06 | 90 | 0 |
| K923022 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1992-09-22 | 91 | 0 |
| K920215 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1992-04-14 | 89 | 0 |
| K915552 | INSTRUMENTARIUM MEGA4 | Instrumentarium Imaging, Inc. | 1992-02-27 | 78 | 0 |
| K912180 | MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM | Instrumentarium Imaging, Inc. | 1991-10-21 | 158 | 0 |
| K912963 | INSTRUMENTARIUM MEGA4 | Instrumentarium Imaging, Inc. | 1991-09-30 | 84 | 0 |
| K910111 | VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS | Instrumentarium Imaging, Inc. | 1991-09-23 | 256 | 0 |
| K896596 | ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL | Instrumentarium Imaging, Inc. | 1991-05-30 | 555 | 0 |
| K904528 | INSTRUMENTARIUM MEGA4, MODIFICATION | Instrumentarium Imaging, Inc. | 1990-11-20 | 50 | 0 |
| K902044 | MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM | Instrumentarium Imaging, Inc. | 1990-08-23 | 108 | 0 |
| K900967 | MODIFIED ALPHA MC-9R C-ARM | Instrumentarium Imaging, Inc. | 1990-05-09 | 68 | 0 |
| K901620 | MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI | Instrumentarium Imaging, Inc. | 1990-05-07 | 32 | 0 |
| K896309 | MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC | Instrumentarium Imaging, Inc. | 1990-01-12 | 72 | 0 |
| K891543 | MAGNAVIEW MOBILE MRI VERSION 110 FHM | Instrumentarium Imaging, Inc. | 1989-06-23 | 98 | 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