Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Dentsply SironaLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Imaging Sciences International with 11 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Nov 10, 2016: i-CAT FLX V series / KaVo 3D eXam+ V series.
| Nov 10, 2016 | i-CAT FLX V series / KaVo 3D eXam+ V seriesK162085 · OAS | 510(k) clearances |
| Aug 26, 2014 | VixWin PlatinumK141451 · LLZ | 510(k) clearances |
| May 14, 2014 | CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEMK133620 · OAS | 510(k) clearances |
| Apr 23, 2014 | DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MACK140445 · LLZ | 510(k) clearances |
| Jul 30, 2012 | DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing SystemClass II · A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being p | Device recalls |
| Jul 3, 2006 | I-CAT SCANNERK061284 · MUH | 510(k) clearances |
| Aug 19, 2005 | DVT SCANNERK051980 · JAK | 510(k) clearances |
| Dec 23, 2004 | SURGPLAN AND PANPLANK041078 · LLZ | 510(k) clearances |
| May 4, 2000 | MULTI-PULSE 2000K001248 · EHD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
