510(k) Report

FDA applicant

Shotwell & Carr, Inc.

Dallas, TX3 decisions1995–19970 recalls

FDA records 3 decisions for Shotwell & Carr, Inc. (Dallas, TX) from 1995 to 1997: 3 510(k) clearances. Most are in product codes KGI (Densitometer, Bone) and JOY (Device, Automated Cell-Locating). 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 Shotwell & Carr, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shotwell & Carr, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KGIDensitometer, Bone1decision
  • JOYDevice, Automated Cell-Locating1decision
  • IPFStimulator, Muscle, Powered1decision

What has FDA decided for it lately?

  • K970824MDX 2000, Digital AnalyzerShotwell & Carr, Inc. · 1997
  • K961011DTX-200 Bone DensitometerShotwell & Carr, Inc. · 1996
  • K950617Smart Wave GS100Shotwell & Carr, Inc. · 1995

All 3 as Shotwell & Carr, Inc. →