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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Image Analysis, Inc. with 10 510(k) clearances. The most recent is a 510(k) clearance dated May 17, 2017: Dynamika.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 17, 2017 | DynamikaK161601 · LLZ | 510(k) clearances |
| Jul 13, 2004 | N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XXK040782 · JAK | 510(k) clearances |
| Jul 30, 2003 | DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUSK031991 · KGI | 510(k) clearances |
| Sep 3, 1999 | QCT BONE MINERAL ANALYSIS SOFTWAREK992246 · KGI | 510(k) clearances |
| Jun 5, 1995 | QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000K952060 · KGI | 510(k) clearances |
| May 11, 1995 | QCT-BONE MINERAL ANALYSIS SOFTWAREK941127 · KGI | 510(k) clearances |
| May 3, 1995 | QCT-BONE MINERAL ANALYSIS PHANTOMK941126 · KGI | 510(k) clearances |
| May 18, 1989 | QCT-LUNG NODULE (TM) ANALYSIS PACKAGEK891931 · JAK | 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
