FDA applicant

Problem Solving Concepts, Inc.

Carmel, IN2 decisions2000–20022 recalls

FDA records 2 decisions for Problem Solving Concepts, Inc. (Carmel, IN) from 2000 to 2002: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and DQK (Computer, Diagnostic, Programmable). 2 recalls are 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 Problem Solving Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Problem Solving Concepts, Inc. since 2007.

Recalls per year

2in 2015

2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Problem Solving Concepts, Inc.’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

Problem Solving Concepts, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?