Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MOT — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
108 daysmedian FDA review time
1296 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201177 | RadGil2 | R3 X-Ray L.L.C | 2020-08-17 | 108 | 0 |
| K181737 | Raycell MK1 | Best Theratronics Limited | 2019-01-02 | 184 | 0 |
| K172087 | SANGRAY | Hitachi , Ltd. | 2017-10-27 | 108 | 0 |
| K161324 | Raycell Mk2 | Best Theratronics Limited | 2016-08-12 | 93 | 0 |
| K082921 | RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 | Rad Source Technologies, Inc. | 2009-02-17 | 139 | 0 |
| K051065 | RAYCELL X-RAY BLOOD IRRADIATOR | Mds Nordion | 2005-05-26 | 30 | 0 |
| K050963 | GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN | Mds Nordion | 2005-05-20 | 32 | 0 |
| K032684 | RAYCELL | Mds Nordion | 2003-09-26 | 28 | 0 |
| K974210 | SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 | Rad-Source, Inc. | 1998-03-30 | 140 | 1 |
| K963497 | GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, V | Nordion International, Inc. | 1996-11-08 | 66 | 0 |
| K952291 | GAMMACELL 3000 ELAN | Nordion International, Inc. | 1995-08-25 | 101 | 0 |
| K915766 | MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS | J. L. Shepherd and Assoc. | 1995-07-12 | 1296 | 0 |
| K915767 | MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS | J. L. Shepherd and Assoc. | 1995-07-12 | 1296 | 0 |
| K865027 | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C | Cis-Us, Inc. | 1987-02-26 | 65 | 0 |
| K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | Syncor Intl. Corp. | 1985-09-19 | 146 | 0 |
| K837346 | MODEL GAMMACELL 1000 | Atomic Energy of Canada | 1983-06-24 | 100 | 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