FDA product code EAH: Cone, Radiographic, Lead-Lined
EAH is the FDA product code for cone, radiographic, lead-lined. It is a Class I device, regulated under 21 CFR 872.1850 and reviewed by the Radiology panel. FDA has cleared 2 510(k) submissions under EAH, from 2 different applicants. The average 510(k) review took 33 days (median 33).
Classification
| Field | Value |
|---|---|
| Device name | Cone, Radiographic, Lead-Lined |
| Device class | Class I |
| Regulation | 21 CFR 872.1850 |
| Review panel | RA — Radiology |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Top EAH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gary E. Hall, Dds | 1 | 1984-03-16 |
| General Electric Co. | 1 | 1977-09-28 |
Most recent EAH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840275 | Gary E. Hall, Dds | CEHPALOMETRIC HEAD POSITIONER | 1984-03-16 | 53 |
| K771748 | General Electric Co. | INTRA ORAL X-RAY CONES | 1977-09-28 | 13 |
Recalls for EAH devices
openFDA lists no recalls for product code EAH.
Frequently asked questions
What is FDA product code EAH?
EAH is the FDA product code for cone, radiographic, lead-lined. It is a Class I device, regulated under 21 CFR 872.1850 and reviewed by the Radiology panel.
What device class is EAH?
Class I, regulation 21 CFR 872.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EAH?
Across 2 cleared submissions the average was 33 days from receipt to decision (median 33).
Which companies have the most EAH clearances?
Gary E. Hall, Dds (1); General Electric Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EAH
- Run a recall and safety report across every EAH manufacturer
- Watch product code EAH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.