Digigraph Diagnostic Work/Station

FDA 510(k) K896099 · Dolphin Imaging Systems

Substantially Equivalent

510(k) numberK896099

Submission

Device name
Digigraph Diagnostic Work/Station
Applicant
Dolphin Imaging Systems
Valencia, CA, US
Received
October 20, 1989
Decision date
January 31, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EAG – Cephalometer
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1830
Specialty
Dental

Other 510(k)s with product code EAG

510(k)DeviceApplicantDecision
K030699Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricEAG · Traditional J. Morita Mfg. Corp.05/29/2003SE
K021372Veraviewepocs Panoramic X-Ray Unit with Cephalometric CapabilityEAG · Traditional J. Morita USA, Inc.06/07/2002SE
K944162Denar Accuceph Cephalometer Imaging SystemEAG · Traditional Teledyne Water Pik11/29/1994SE
K920189Gx-C CephalometerEAG · Traditional Gendex Corp.04/28/1992SE
K870243Burnett TMJ ApplianceEAG · Traditional Medrad, Inc.02/24/1987SE
K842463GX CephEAG · Traditional Gendex Corp.08/02/1984SE
K833006Cephalometer & FixatorEAG · Traditional Modern Systems, Inc.01/03/1984SE
K810538PlasticephEAG · Traditional Morningstar Dental Co.04/29/1981SE
K781287Dental X-Ray Unit W/Cephalometric AttachEAG · Traditional Siemens Corp.09/11/1978SE

Questions and answers

When was Digigraph Diagnostic Work/Station cleared by the FDA?

Digigraph Diagnostic Work/Station (K896099) received a 510(k) decision of Substantially Equivalent on January 31, 1991, 468 days after the submission was received.

What is the product code of K896099?

The FDA product code is EAG – Cephalometer, a Class II (moderate risk) device regulated under 21 CFR 872.1830.