Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IZW — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
189 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101039 | SHIMADZU COLLIMATOR R-300 | Shimadzu Corp. | 2010-09-20 | 159 | 0 |
| K093572 | R650 QDASM COLLIMATOR | Omega Medical Imaging, Inc. | 2010-02-03 | 77 | 0 |
| K090578 | SHIMADZU COLLIMATOR R-30H | Shimadzu Corp. | 2009-11-06 | 248 | 1 |
| K091517 | RALCO, MODEL R225 ACS | Ralco S.R.L. | 2009-07-14 | 53 | 0 |
| K083029 | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR | Ralco S.R.L. | 2008-12-05 | 56 | 0 |
| K072780 | MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR | Ralco S.R.L. | 2007-11-26 | 59 | 0 |
| K073124 | COLLIMARE COLLIMATOR FAMILY | Collimare, LLC | 2007-11-16 | 10 | 0 |
| K050092 | R605 FACS COLLIMETER | Omega Medical Imaging, Inc. | 2005-01-31 | 17 | 0 |
| K031597 | DUNLEE FORMAT COLLIMATOR FAMILY | Philips Medical Systems North America Co. | 2003-07-21 | 61 | 0 |
| K990423 | PHILIPS NICOL COLLIMATOR FAMILY | Philips Medical Systems, Inc. | 1999-03-15 | 32 | 0 |
| K984414 | XRE COLLIMATOR WITH SPECTRAL FILTER | Trex Medical Corp. | 1998-12-30 | 20 | 0 |
| K960998 | XRE COLLIMATOR | Xre Corp. | 1996-04-03 | 22 | 0 |
| K951372 | PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVI | Philips Medical Systems, Inc. | 1995-05-04 | 38 | 1 |
| K920725 | COLLIMATOR F-20 | Shimadzu Medical Systems | 1992-04-16 | 58 | 0 |
| K920733 | STEREO COLLIMATOR RF-T SERIES | Shimadzu Medical Systems | 1992-04-16 | 58 | 0 |
| K911127 | COLLIMASTER-90 | Varian Assoc., Inc. | 1991-09-19 | 189 | 0 |
| K894142 | ULTRANET-S COLLIMATOR | GE Medical Systems | 1989-11-06 | 146 | 0 |
| K861942 | COLLIMATOR MODEL A280BLE & MODEL A280-BLM | D&R X-Ray Products, Inc. | 1986-07-25 | 66 | 0 |
| K862340 | SENTEC LASER GUIDE LINE, MODEL SGL-05 | Sentec Corp. | 1986-07-11 | 21 | 0 |
| K843244 | LIGHT BEAM COLLIMATOR | Dealers X-Ray Co., Inc. | 1984-09-14 | 25 | 0 |
| K833779 | YTTRO FILTER | Yttro Corp. | 1984-06-05 | 222 | 0 |
| K810598 | X-RAY COLLIMATING DEVICES | Midmark Corp. | 1981-04-10 | 35 | 0 |
| K810590 | P.R.M. 80 | T.E.M. Instruments , Ltd. | 1981-04-10 | 37 | 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