Home / 510(k) Clearances / K030699

510(k) K030699

VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC by J. Morita Mfg. Corp. — Product Code EAG

K030699 is an FDA 510(k) premarket notification submitted by J. Morita Mfg. Corp. for the device "VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC". The FDA issued a decision of Substantially Equivalent on May 29, 2003. 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
May 29, 2003
Date Received
March 6, 2003
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

  • 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)
  • K896099 — DIGIGRAPH DIAGNOSTIC WORK/STATION (January 31, 1991)
  • 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