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510(k) K954200

VOXGRAM by Voxel — Product Code IWZ

K954200 is an FDA 510(k) premarket notification submitted by Voxel for the device "VOXGRAM". The FDA issued a decision of Substantially Equivalent on September 29, 1995. The device falls under product code IWZ (Film, Radiographic), a Class I device regulated under 21 CFR 892.1840. Voxel has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1995
Date Received
September 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Film, Radiographic
Device Class
Class I
Regulation Number
892.1840
Review Panel
RA
Submission Type

Other clearances by Voxel

  • K954198 — VOXCAM (September 29, 1995)
  • K954199 — VOXBOX (September 29, 1995)

Other clearances for product code IWZ

  • K970154 — KODAK EKTASIAN HG FILM (EHG-15) (April 4, 1997)
  • K931604 — 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE (July 21, 1993)
  • K931605 — 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE (July 20, 1993)
  • K920539 — ORWO X-RAY FILM (June 30, 1992)
  • K884827 — KODAK DENTAL BARRIER PAC (January 30, 1989)
  • K862944 — KODAK CFT FILM SO-141 (August 12, 1986)
  • K862415 — TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM (July 1, 1986)
  • K860797 — MEDICAL X-RAY FILM (March 13, 1986)
  • K844554 — BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG (February 21, 1985)
  • K840806 — FR MEDICAL X-RAY FILM (April 24, 1984)

FDA data resources