Computerized Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Computerized Medical Systems, Inc.” (first 1985, latest 2011), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Elekta, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | 9 | 9 |
| IYE | Accelerator, Linear, Medical | 5 | 5 |
| KPQ | System, Simulation, Radiation Therapy | 3 | 3 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 | 1 |
| JAD | System, Therapeutic, X-Ray | 1 | 1 |
Review panels
- Radiology (21)
- Cardiovascular (2)
Most recent Computerized Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110730 | MONACO RTP SYSTEM | MUJ | 2011-06-24 | 100 |
| K102216 | XIO RTP SYSTEM | MUJ | 2010-10-01 | 56 |
| K092132 | XIO RTP SYSTEM | MUJ | 2009-09-24 | 71 |
| K091179 | MONACO RTP SYSTEM, VMAT OPTION | MUJ | 2009-07-16 | 84 |
| K080799 | ATLAS-BASED AUTOSEGMENTATION | LHN | 2008-08-07 | 139 |
| K071938 | MONACO RTP SYSTEM | MUJ | 2007-10-01 | 80 |
| K032762 | XIO RADIATION TREATMENT PLANNING SYSTEM | IYE | 2003-12-02 | 88 |
| K032100 | I-BEAM | IYE | 2003-10-02 | 86 |
| K020027 | FOCUS RADIATION TREATMENT PLANNING SYSTEM | MUJ | 2002-10-08 | 277 |
| K013112 | FOCAL SIM | MUJ | 2001-12-05 | 78 |
13 earlier clearances. See the full list in Caduvo.
Recalls
32 product recalls in 32 recall events; 0 initiated in the last five years. Most recent: 2012-04-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Computerized Imaging Reference Systems, Inc. (2 510(k)s)
- Computerized Screening, Inc. (2 510(k)s)
- Computerized Anesthesia Systems, Inc. (1 510(k)s)
- Computerized Functional Testing Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Computerized Medical Systems, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Computerized Medical Systems, Inc.” (first 1985, latest 2011), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Computerized Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Computerized Medical Systems, Inc. is 90 days.
Which FDA product codes appear under Computerized Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are MUJ (System, Planning, Radiation Therapy Treatment, 9); IYE (Accelerator, Linear, Medical, 5); KPQ (System, Simulation, Radiation Therapy, 3).
Next steps
- See all 23 Computerized Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MUJ, Computerized Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.