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510(k) K844554

BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG by Belmont Equipment Corp. — Product Code IWZ

K844554 is an FDA 510(k) premarket notification submitted by Belmont Equipment Corp. for the device "BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG". The FDA issued a decision of Substantially Equivalent on February 21, 1985. The device falls under product code IWZ (Film, Radiographic), a Class I device regulated under 21 CFR 892.1840. Belmont Equipment Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1985
Date Received
November 21, 1984
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 Belmont Equipment Corp.

  • K000799 — BELMONT UNIT, MODEL 2000 SERIES (May 17, 2000)
  • K983661 — BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES (January 12, 1999)
  • K963699 — BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY (December 23, 1996)
  • K900681 — PANORAMIC MODEL X-CALIBER X-RAY (May 23, 1990)
  • K874238 — MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY (December 7, 1987)
  • K870300 — BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75 (March 25, 1987)
  • K861328 — NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY (April 24, 1986)
  • K852019 — BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD (June 5, 1985)
  • K834279 — ACURAY 071A DENTAL INTRAORAL X-RAY (December 29, 1983)
  • K832065 — ACURACY 071, DENTAL, INTRAORAL-X-RAY (September 12, 1983)

Other clearances for product code IWZ

  • K970154 — KODAK EKTASIAN HG FILM (EHG-15) (April 4, 1997)
  • K954200 — VOXGRAM (September 29, 1995)
  • 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)
  • K840806 — FR MEDICAL X-RAY FILM (April 24, 1984)

FDA data resources