Confirma, Inc.: FDA clearances and approvals
Confirma, Inc. has 9 FDA 510(k) clearances (first 2002, latest 2009), across 3 product codes in 1 review panel. Median 510(k) review time: 45 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 5 | 5 |
| MOS | Coil, Magnetic Resonance, Specialty | 3 | 3 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
Review panels
- Radiology (9)
Most recent Confirma, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092954 | CADSTREAM VERSION 5 | LLZ | 2009-11-06 | 42 |
| K081556 | CADSTREAM, VERSION 5.0 | LLZ | 2009-02-02 | 244 |
| K071534 | CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS | MOS | 2007-07-09 | 34 |
| K060547 | ACCESS BREAST COIL 4/SMS | MOS | 2006-03-29 | 28 |
| K052045 | ACCESS BREAST COIL | MOS | 2005-08-24 | 27 |
| K043216 | CADSTREAM VERSION 4.0 | LLZ | 2005-01-06 | 45 |
| K041020 | CADSTREAM VERSION 3.1 | LNH | 2004-07-07 | 78 |
| K031779 | CADSTREAM | LLZ | 2003-08-06 | 57 |
| K013574 | ACCENT | LLZ | 2002-01-15 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Confirma, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Confirma, Inc.'s product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances does Confirma, Inc. have?
Confirma, Inc. has 9 FDA 510(k) clearances (first 2002, latest 2009), across 3 product codes in 1 review panel.
How long does FDA take to clear Confirma, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Confirma, Inc.'s cleared 510(k)s is 45 days.
What devices does Confirma, Inc. make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 5); MOS (Coil, Magnetic Resonance, Specialty, 3); LNH (System, Nuclear Magnetic Resonance Imaging, 1).
Has Confirma, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Confirma, Inc. Related entities may recall under other names.
Next steps
- See all 9 Confirma, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Confirma, Inc.'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.