Imatron, Inc.: FDA clearances and approvals
Imatron, Inc. has 11 FDA 510(k) clearances (first 1983, latest 2000), across 5 product codes in 1 review panel. Median 510(k) review time: 71 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 7 | 7 |
| IXG | Phantom, Anthropomorphic, Radiographic | 1 | 1 |
| KXJ | Table, Radiologic | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (10)
Most recent Imatron, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001550 | EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR | LLZ | 2000-12-11 | 207 |
| K000359 | EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO | JAK | 2000-03-17 | 42 |
| K992740 | EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS | JAK | 1999-11-09 | 85 |
| K972903 | IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS | JAK | 1997-11-04 | 90 |
| K972879 | ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION | JAK | 1997-10-15 | 71 |
| K913352 | C-150 ULTRAFAST CT SCANNER | JAK | 1991-11-29 | 126 |
| K874934 | UNIVERSAL EXAMINATION TABLE | KXJ | 1988-01-19 | 46 |
| K872615 | IMATRON C-100 ULTRAFAST CT SCANNER | JAK | 1987-09-23 | 79 |
| K864046 | C-IOO MOBILE CINE CT UNIT | JAK | 1986-11-10 | 25 |
| K840131 | COMPUTED TOMOGRAPHY CALIBRATION PHANT | IXG | 1984-02-21 | 42 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Imatron, 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 Imatron, Inc. have?
Imatron, Inc. has 11 FDA 510(k) clearances (first 1983, latest 2000), across 5 product codes in 1 review panel.
How long does FDA take to clear Imatron, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Imatron, Inc.'s cleared 510(k)s is 71 days.
What devices does Imatron, Inc. make?
Its most frequent FDA product codes are JAK (System, X-Ray, Tomography, Computed, 7); IXG (Phantom, Anthropomorphic, Radiographic, 1); KXJ (Table, Radiologic, 1).
Has Imatron, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Imatron, Inc. Related entities may recall under other names.
Next steps
- See all 11 Imatron, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Imatron, 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.