FDA product code EAG: Cephalometer
EAG is the FDA product code for cephalometer. It is a Class II device, regulated under 21 CFR 872.1830 and reviewed by the Radiology panel. FDA has cleared 10 510(k) submissions under EAG, from 9 different applicants. The average 510(k) review took 109 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | Cephalometer |
| Device class | Class II |
| Regulation | 21 CFR 872.1830 |
| Review panel | RA — Radiology |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every EAG clearance
Top EAG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gendex Corp. | 2 | 1992-04-28 |
| J. Morita Mfg. Corp. | 1 | 2003-05-29 |
| J. Morita USA, Inc. | 1 | 2002-06-07 |
| Teledyne Water Pik | 1 | 1994-11-29 |
| Dolphin Imaging Systems | 1 | 1991-01-31 |
4 more applicants have EAG clearances. See the full list in Caduvo.
Most recent EAG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030699 | J. Morita Mfg. Corp. | VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC | 2003-05-29 | 84 |
| K021372 | J. Morita USA, Inc. | VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY | 2002-06-07 | 38 |
| K944162 | Teledyne Water Pik | DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM | 1994-11-29 | 95 |
| K920189 | Gendex Corp. | GX-C CEPHALOMETER | 1992-04-28 | 104 |
| K896099 | Dolphin Imaging Systems | DIGIGRAPH DIAGNOSTIC WORK/STATION | 1991-01-31 | 468 |
Recalls for EAG devices
openFDA lists no recalls for product code EAG.
Frequently asked questions
What is FDA product code EAG?
EAG is the FDA product code for cephalometer. It is a Class II device, regulated under 21 CFR 872.1830 and reviewed by the Radiology panel.
What device class is EAG?
Class II, regulation 21 CFR 872.1830. Typical premarket route: 510(k).
How long does a 510(k) take for product code EAG?
Across 10 cleared submissions the average was 109 days from receipt to decision (median 73).
Which companies have the most EAG clearances?
Gendex Corp. (2); J. Morita Mfg. Corp. (1); J. Morita USA, Inc. (1); Teledyne Water Pik (1); Dolphin Imaging Systems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EAG
- Run a recall and safety report across every EAG manufacturer
- Watch product code EAG 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.
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