Home / 510(k) Clearances / K896099

510(k) K896099

DIGIGRAPH DIAGNOSTIC WORK/STATION by Dolphin Imaging Systems — Product Code EAG

K896099 is an FDA 510(k) premarket notification submitted by Dolphin Imaging Systems for the device "DIGIGRAPH DIAGNOSTIC WORK/STATION". The FDA issued a decision of Substantially Equivalent on January 31, 1991. The device falls under product code EAG (Cephalometer), a Class II device regulated under 21 CFR 872.1830.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1991
Date Received
October 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cephalometer
Device Class
Class II
Regulation Number
872.1830
Review Panel
RA
Submission Type

Other clearances for product code EAG

  • K030699 — VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC (May 29, 2003)
  • K021372 — VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY (June 7, 2002)
  • K944162 — DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM (November 29, 1994)
  • K920189 — GX-C CEPHALOMETER (April 28, 1992)
  • K870243 — BURNETT TMJ APPLIANCE (February 24, 1987)
  • K842463 — GX CEPH (August 2, 1984)
  • K833006 — CEPHALOMETER & FIXATOR (January 3, 1984)
  • K810538 — PLASTICEPH (April 29, 1981)
  • K781287 — DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH (September 11, 1978)

FDA data resources