FDA applicant

Aspen Imaging Healthcare, Inc.

Plano, TX2 decisions2024–20250 recalls

FDA records 2 decisions for Aspen Imaging Healthcare, Inc. (Plano, TX) from 2024 to 2025: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Its devices cite 2 predicates, 0 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 Aspen Imaging Healthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Aspen Imaging Healthcare, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aspen Imaging Healthcare, 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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Other applicant names beginning “Aspen”

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

Aspen Laboratories, Inc. 55 Aspen Labs 6 Aspen Glove Sdn. Bhd. 4 Aspen Surgical Products, Inc. 2 Aspen Laser Systems, LLC 2 Aspen Medical, Ltd. 1

Aspen Imaging Healthcare, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Aspen”