Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Panoramic Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
156 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152489 | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray | Panoramic Corp. | 2016-02-04 | 156 | 0 |
| K141130 | ENCOMPASS | Panoramic Corp. | 2014-07-30 | 90 | 0 |
| K110371 | ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY | Panoramic Corp. | 2011-03-17 | 37 | 0 |
| K043557 | MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS | Panoramic Corp. | 2005-01-13 | 17 | 0 |
| K943532 | PANORAMIC CORPORATION HDLX | Panoramic Corp. | 1994-12-07 | 139 | 0 |
| K882436 | LASER - 1000 | Panoramic Corp. | 1988-08-04 | 51 | 2 |
| K870236 | PANORAMIC X-RAY MODEL PC-1000 | Panoramic Corp. | 1987-02-13 | 23 | 2 |
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