FDA product code EAM: Screen, Intensifying, Radiographic
EAM is the FDA product code for screen, intensifying, radiographic. It is a Class I device, regulated under 21 CFR 892.1960 and reviewed by the Radiology panel. FDA has cleared 35 510(k) submissions under EAM, from 12 different applicants. The average 510(k) review took 76 days (median 46). FDA has posted 4 recalls for EAM devices.
Classification
| Field | Value |
|---|---|
| Device name | Screen, Intensifying, Radiographic |
| Device class | Class I |
| Regulation | 21 CFR 892.1960 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EAM clearance
Top EAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 11 | 1993-06-08 |
| Fujifilm Medical System U.S.A., Inc. | 7 | 1994-08-22 |
| Eastman Kodak Company | 7 | 1994-07-29 |
| Mci Optonix, Inc. | 2 | 1994-03-30 |
| Sterling Diagnostic Imaging, Inc. | 1 | 1997-12-22 |
7 more applicants have EAM clearances. See the full list in Caduvo.
Most recent EAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974423 | Sterling Diagnostic Imaging, Inc. | ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL | 1997-12-22 | 28 |
| K963913 | Konica Medical Corp. | MD100 & MM150 | 1997-10-08 | 373 |
| K954161 | Jpi Healthcare Co, Ltd. | JPI INTENSIFYING SCREEN | 1996-02-02 | 150 |
| K943823 | Fujifilm Medical System U.S.A., Inc. | FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 | 1994-08-22 | 68 |
| K943822 | Fujifilm Medical System U.S.A., Inc. | FUJI UM MAMMO SERIES INTENSIFY SCREENS: | 1994-08-22 | 68 |
Recalls for EAM devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-03-30.
Frequently asked questions
What is FDA product code EAM?
EAM is the FDA product code for screen, intensifying, radiographic. It is a Class I device, regulated under 21 CFR 892.1960 and reviewed by the Radiology panel.
What device class is EAM?
Class I, regulation 21 CFR 892.1960. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EAM?
Across 35 cleared submissions the average was 76 days from receipt to decision (median 46).
Which companies have the most EAM clearances?
E.I. Dupont DE Nemours & Co., Inc. (11); Fujifilm Medical System U.S.A., Inc. (7); Eastman Kodak Company (7); Mci Optonix, Inc. (2); Sterling Diagnostic Imaging, Inc. (1).
Have EAM devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2004-03-30.
Next steps
- Run an FDA pathway report with predicate devices for product code EAM
- Run a recall and safety report across every EAM manufacturer
- Watch product code EAM 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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