510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
EAMClass I

Screen, Intensifying, Radiographic

21 CFR 892.1960 / Radiology
FDA source (opens on fda.gov)

EAM is the FDA product code for Screen, Intensifying, Radiographic, a class I device type, regulated under 21 CFR 892.1960. As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
EAM
Device name
Screen, Intensifying, Radiographic
Regulation
21 CFR 892.1960
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
35
Ingested recalls
4

Clearances, product code EAM

By decision year
35 clearances under product code EAM with a decision year between 1977 and 1997, 1994 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code EAM by decision year
YearClearances
19773
19791
19812
19841
19851
19861
19872
19891
19906
19923
19932
19949
19961
19972

Applicants with the most clearances

Product code EAM
Applicants holding the most 510(k) clearances under product code EAM
ApplicantClearances
E.I. Dupont de Nemours & Co., Inc.11
Eastman Kodak Company7
FUJIFILM Healthcare Americas Corporation7
Mci Optonix2
Dupont Medical Products1
General Electric Co.1
Infab, LLC.1
JPI Healthcare Co., Ltd1
Konica Medical Corp.1
Parexel Intl. Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code