FDA Product Code
FDA Product Code QJU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2100
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261042 | Lung Guidance | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-10-02 | Traditional | PDF ↗ |
| K260338 | ThinkSono Guidance | ThinkSono GmbH | 2026-07-15 | Traditional | PDF ↗ |
| K260780 | HeartFocus | Deski | 2026-06-03 | Special | PDF ↗ |
| K251416 | UltraSight Guidance | Ultrasight , Ltd. | 2025-12-17 | Traditional | PDF ↗ |
| K242807 | HeartFocus (V.1.1.1) | Deski | 2025-04-04 | Traditional | PDF ↗ |
| K243065 | Cardiac Guidance | Caption Health, Inc. | 2025-01-15 | Traditional | PDF ↗ |
| K223347 | UltraSight AI Guidance | Ultrasight, Inc. | 2023-07-24 | Traditional | PDF ↗ |
| K201992 | Caption Guidance | Caption Health | 2020-09-18 | Traditional | PDF ↗ |
| K200755 | Caption Guidance | Caption Health | 2020-04-16 | Traditional | PDF ↗ |
| DEN190040 | Caption Guidance | Bay Labs, Inc. | 2020-02-07 | Direct | — |
Product code QJU · Class II · Radiology. Data: openFDA.