Atlas FDA

EAG

10 FDA 510(k) clearances · Product code

84 daysmedian time to decision
468 days90th percentile
10clearances measured

FDA profile

Official device name
Cephalometer
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1830
Medical specialty
Dental
Flags
Third-party review eligible
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RecordFirmDate
VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC (K030699)J. Morita Mfg. Corp.2003-05-29
VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY (K021372)J. Morita USA, Inc.2002-06-07
DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM (K944162)Teledyne Water Pik1994-11-29
GX-C CEPHALOMETER (K920189)Gendex Corp.1992-04-28
DIGIGRAPH DIAGNOSTIC WORK/STATION (K896099)Dolphin Imaging Systems1991-01-31
BURNETT TMJ APPLIANCE (K870243)Medrad, Inc.1987-02-24
GX CEPH (K842463)Gendex Corp.1984-08-02
CEPHALOMETER & FIXATOR (K833006)Modern Systems, Inc.1984-01-03
PLASTICEPH (K810538)Morningstar Dental Co.1981-04-29
DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH (K781287)Siemens Corp.1978-09-11

Track EAG automatically

Every clearance here is in the API, with alerts when new ones post.