Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imatron, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
126 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001550 | EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C | Imatron, Inc. | 2000-12-11 | 207 | 0 |
| K000359 | EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM | Imatron, Inc. | 2000-03-17 | 42 | 0 |
| K992740 | EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM | Imatron, Inc. | 1999-11-09 | 85 | 0 |
| K972903 | IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTEN | Imatron, Inc. | 1997-11-04 | 90 | 0 |
| K972879 | ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION | Imatron, Inc. | 1997-10-15 | 71 | 0 |
| K913352 | C-150 ULTRAFAST CT SCANNER | Imatron, Inc. | 1991-11-29 | 126 | 0 |
| K874934 | UNIVERSAL EXAMINATION TABLE | Imatron, Inc. | 1988-01-19 | 46 | 0 |
| K872615 | IMATRON C-100 ULTRAFAST CT SCANNER | Imatron, Inc. | 1987-09-23 | 79 | 0 |
| K864046 | C-IOO MOBILE CINE CT UNIT | Imatron, Inc. | 1986-11-10 | 25 | 0 |
| K840131 | COMPUTED TOMOGRAPHY CALIBRATION PHANT | Imatron, Inc. | 1984-02-21 | 42 | 0 |
| K828669 | COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100 | Imatron, Inc. | 1983-01-14 | 45 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda