510(k) Report

FDA applicant

Osteometer Meditech A/S

Dallas, TX3 decisions1997–20000 recalls

FDA records 3 decisions for Osteometer Meditech A/S (Dallas, TX) from 1997 to 2000: 2 510(k) clearances and 1 original PMA approval. Most are in product codes KGI (Densitometer, Bone) and MUA (Bone Sonometer). 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 Osteometer Meditech A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Osteometer Meditech A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Osteometer Meditech A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • KGIDensitometer, Bone2decisions
  • MUABone Sonometer1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K964562DTX-200 Bone DensitometerOsteometer Meditech A/S · 19972cite it

What has FDA decided for it lately?

  • P980010Dtu-One Ultrasound ScannerOsteometer Meditech A/S · 2000
  • K964562DTX-200 Bone DensitometerOsteometer Meditech A/S · 1997
  • K963789DTX-100 Bone DensitometerOsteometer Meditech A/S · 1997

All 3 as Osteometer Meditech A/S →

Other applicant names beginning “Osteometer”

FDA records each applicant name separately; these may or may not be the same firm.

Osteometer Biotech A/S 2Osteometer Meditech, Inc. 1