Impac Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Impac Medical Systems, Inc.” (first 1991, latest 2015), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 85 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 | 2 | 54 |
| 2013 | 1 | 58 |
| 2014 | 1 | 85 |
| 2015 | 1 | 60 |
| 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 | 8 | 8 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 2 |
| KPQ | System, Simulation, Radiation Therapy | 1 | 1 |
Review panels
- Radiology (13)
Most recent Impac Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151233 | Monaco | MUJ | 2015-07-07 | 60 |
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | IYE | 2014-09-05 | 85 |
| K132971 | MONACO | MUJ | 2013-11-20 | 58 |
| K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | IYE | 2012-12-12 | 58 |
| K120067 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | IYE | 2012-02-28 | 50 |
| K043412 | MODIFICATION TO: VIEWSTATION | LLZ | 2004-12-20 | 10 |
| K013531 | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 | KPQ | 2001-11-07 | 15 |
| K011694 | VIEWSTATION | LLZ | 2001-08-29 | 90 |
| K991133 | MLC FIT | IYE | 2000-03-27 | 360 |
| K981313 | SEQUENCER | IYE | 1998-07-09 | 90 |
3 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2012-06-08.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Impac Medical Systems, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Impac Medical Systems, Inc.” (first 1991, latest 2015), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Impac Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Impac Medical Systems, Inc. is 85 days.
Which FDA product codes appear under Impac Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 8); LLZ (System, Image Processing, Radiological, 2); MUJ (System, Planning, Radiation Therapy Treatment, 2).
Next steps
- See all 13 Impac Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Impac 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.