Image Analysis, Inc.: FDA clearances and approvals
Image Analysis, Inc. has 9 FDA 510(k) clearances (first 1985, latest 2004), across 2 product codes in 1 review panel. 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 |
|---|---|---|---|
| KGI | Densitometer, Bone | 7 | 7 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
Review panels
- Radiology (9)
Most recent Image Analysis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040782 | N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX | JAK | 2004-07-13 | 109 |
| K031991 | DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS | KGI | 2003-07-30 | 33 |
| K992246 | QCT BONE MINERAL ANALYSIS SOFTWARE | KGI | 1999-09-03 | 59 |
| K952060 | QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000 | KGI | 1995-06-05 | 34 |
| K941127 | QCT-BONE MINERAL ANALYSIS SOFTWARE | KGI | 1995-05-11 | 428 |
| K941126 | QCT-BONE MINERAL ANALYSIS PHANTOM | KGI | 1995-05-03 | 420 |
| K891931 | QCT-LUNG NODULE (TM) ANALYSIS PACKAGE | JAK | 1989-05-18 | 51 |
| K852510 | COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS | KGI | 1985-10-18 | 128 |
| K852509 | QCT-BONE MINERAL PHANTOM | KGI | 1985-10-18 | 128 |
Recalls
openFDA lists no recalls under a recalling firm named Image Analysis, 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.
Frequently asked questions
How many FDA 510(k) clearances does Image Analysis, Inc. have?
Image Analysis, Inc. has 9 FDA 510(k) clearances (first 1985, latest 2004), across 2 product codes in 1 review panel.
How long does FDA take to clear Image Analysis, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Image Analysis, Inc.'s cleared 510(k)s is 109 days.
What devices does Image Analysis, Inc. make?
Its most frequent FDA product codes are KGI (Densitometer, Bone, 7); JAK (System, X-Ray, Tomography, Computed, 2).
Has Image Analysis, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Image Analysis, Inc. Related entities may recall under other names.
Next steps
- See all 9 Image Analysis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGI, Image Analysis, 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.