Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Computerized Medical Systems, Inc. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
277 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110730 | MONACO RTP SYSTEM | Computerized Medical Systems, Inc. | 2011-06-24 | 100 | 5 |
| K102216 | XIO RTP SYSTEM | Computerized Medical Systems, Inc. | 2010-10-01 | 56 | 6 |
| K092132 | XIO RTP SYSTEM | Computerized Medical Systems, Inc. | 2009-09-24 | 71 | 12 |
| K091179 | MONACO RTP SYSTEM, VMAT OPTION | Computerized Medical Systems, Inc. | 2009-07-16 | 84 | 5 |
| K080799 | ATLAS-BASED AUTOSEGMENTATION | Computerized Medical Systems, Inc. | 2008-08-07 | 139 | 0 |
| K071938 | MONACO RTP SYSTEM | Computerized Medical Systems, Inc. | 2007-10-01 | 80 | 5 |
| K032762 | XIO RADIATION TREATMENT PLANNING SYSTEM | Computerized Medical Systems, Inc. | 2003-12-02 | 88 | 0 |
| K032100 | I-BEAM | Computerized Medical Systems, Inc. | 2003-10-02 | 86 | 0 |
| K020027 | FOCUS RADIATION TREATMENT PLANNING SYSTEM | Computerized Medical Systems, Inc. | 2002-10-08 | 277 | 0 |
| K013112 | FOCAL SIM | Computerized Medical Systems, Inc. | 2001-12-05 | 78 | 10 |
| K002147 | FOCUS | Computerized Medical Systems, Inc. | 2000-10-13 | 88 | 0 |
| K000137 | ENHANCED COMPENSATING FILTER | Computerized Medical Systems, Inc. | 2000-04-17 | 90 | 0 |
| K981535 | FOCUS PILOT CONTOURING WORKSTATION | Computerized Medical Systems, Inc. | 1999-04-02 | 338 | 0 |
| K973936 | FOCUS RTP SYSTEM | Computerized Medical Systems, Inc. | 1998-06-01 | 229 | 0 |
| K915691 | FOCUS RTP | Computerized Medical Systems, Inc. | 1995-02-16 | 1151 | 0 |
| K921108 | CMS RECORD AND VERIFY | Computerized Medical Systems, Inc. | 1992-11-02 | 238 | 0 |
| K913674 | RECORD AND VERIFY MEVATRON ADAPTER | Computerized Medical Systems, Inc. | 1991-11-22 | 95 | 0 |
| K913017 | MODULEX RTP SYSTEM | Computerized Medical Systems, Inc. | 1991-10-17 | 100 | 0 |
| K882484 | CMS RECORD AND VERIFY SYSTEM | Computerized Medical Systems, Inc. | 1988-12-21 | 189 | 0 |
| K863535 | LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD. | Computerized Medical Systems, Inc. | 1987-01-06 | 117 | 0 |
| K863534 | LIFE-WATCH MONITOR LT-8 | Computerized Medical Systems, Inc. | 1986-11-21 | 71 | 0 |
| K854880 | RADIATION BEAM DATA ACQUISTIOIN SYSTEMS | Computerized Medical Systems, Inc. | 1986-01-10 | 35 | 0 |
| K853964 | COMPUTERIZED RADIATION TREATMENT PLANNING SYS | Computerized Medical Systems, Inc. | 1985-12-05 | 80 | 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