Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Impac Medical Systems, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
360 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151233 | Monaco | Impac Medical Systems, Inc. | 2015-07-07 | 60 | 3 |
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | Impac Medical Systems, Inc. | 2014-09-05 | 85 | 2 |
| K132971 | MONACO | Impac Medical Systems, Inc. | 2013-11-20 | 58 | 2 |
| K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | Impac Medical Systems, Inc. | 2012-12-12 | 58 | 4 |
| K120067 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | Impac Medical Systems, Inc. | 2012-02-28 | 50 | 2 |
| K043412 | MODIFICATION TO: VIEWSTATION | Impac Medical Systems, Inc. | 2004-12-20 | 10 | 0 |
| K013531 | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 | Impac Medical Systems, Inc. | 2001-11-07 | 15 | 0 |
| K011694 | VIEWSTATION | Impac Medical Systems, Inc. | 2001-08-29 | 90 | 0 |
| K991133 | MLC FIT | Impac Medical Systems, Inc. | 2000-03-27 | 360 | 0 |
| K981313 | SEQUENCER | Impac Medical Systems, Inc. | 1998-07-09 | 90 | 10 |
| K962335 | MLC FIT | Impac Medical Systems, Inc. | 1997-02-06 | 234 | 0 |
| K942346 | IMAGERT | Impac Medical Systems, Inc. | 1995-05-15 | 364 | 0 |
| K913612 | SEQUENCER | Impac Medical Systems, Inc. | 1991-12-19 | 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