Nomos Corp.: FDA clearances and approvals
Nomos Corp. has 21 FDA 510(k) clearances (first 1993, latest 2007), across 5 product codes in 2 review panels. Median 510(k) review time: 109 days.
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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 12 | 12 |
| HAW | Neurological Stereotaxic Instrument | 3 | 3 |
| JAI | Couch, Radiation Therapy, Powered | 3 | 3 |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 2 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 | 1 |
Review panels
Most recent Nomos Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070611 | BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6 | IYE | 2007-07-11 | 128 |
| K060895 | NOMOSSTAT, VERSION 1.0 | IYE | 2006-07-21 | 109 |
| K042875 | NAVIGATOR | IYE | 2005-07-01 | 256 |
| K032209 | NOMOS CORVUS 5.0M | MUJ | 2003-08-21 | 34 |
| K013036 | NOMOS MOTORIZED CRANE II | JAI | 2001-12-07 | 88 |
| K993675 | PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM | MUJ | 2000-09-05 | 309 |
| K993359 | RAPTOR TREATMENT PLANNING SYSTEM | IYE | 1999-12-21 | 76 |
| K991966 | THE NOMOS CHANE II | IYE | 1999-09-03 | 85 |
| K981424 | NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM | IYE | 1998-07-17 | 88 |
| K974310 | NOMOS SLIT COLLIMATOR (BEAK) | IYE | 1998-02-06 | 81 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nomos Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Nomos Corp. have?
Nomos Corp. has 21 FDA 510(k) clearances (first 1993, latest 2007), across 5 product codes in 2 review panels.
How long does FDA take to clear Nomos Corp.'s 510(k)s?
The median time from FDA receipt to decision across Nomos Corp.'s cleared 510(k)s is 109 days.
What devices does Nomos Corp. make?
Its most frequent FDA product codes are IYE (Accelerator, Linear, Medical, 12); HAW (Neurological Stereotaxic Instrument, 3); JAI (Couch, Radiation Therapy, Powered, 3).
Has Nomos Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Nomos Corp. Related entities may recall under other names.
Next steps
- See all 21 Nomos Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Nomos Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.