510(k) Report

FDA applicant

Alara, Inc.

Fremont, CA6 decisions2000–20110 recalls

FDA records 6 decisions for Alara, Inc. (Fremont, CA) from 2000 to 2011: 6 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and KGI (Densitometer, Bone). Its devices cite 8 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Alara, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Alara, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Alara, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)5decisions
  • KGIDensitometer, Bone1decision

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K032210Alara Crystalview Computed Radiography SystemAlara, Inc. · 20031cites it
  • K061538Alara Crystalview Computed Radiography System, Model R200Alara, Inc. · 20061cites it
  • K000162Metriscan Bone Density SystemAlara, Inc. · 20001cites it
  • K071682Crystalview T-Series Computed Radiography System, Models T110 (with Eraser) and T100 (Without Eraser)Alara, Inc. · 20071cites it

What has FDA decided for it lately?

  • K102479Alara T210 Computed Radiography SystemAlara, Inc. · 2011
  • K071682Crystalview T-Series Computed Radiography System, Models T110 (with Eraser) and T100 (Without Eraser)Alara, Inc. · 2007
  • K062390Crystalview R200Alara, Inc. · 2006
  • K061538Alara Crystalview Computed Radiography System, Model R200Alara, Inc. · 2006
  • K032210Alara Crystalview Computed Radiography SystemAlara, Inc. · 2003
  • K000162Metriscan Bone Density SystemAlara, Inc. · 2000

All 6 as Alara, Inc. →