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510(k) K834614

WILCOR-XR RP-L MEDICAL FILM by Cea America Corp. — Product Code IWZ

K834614 is an FDA 510(k) premarket notification submitted by Cea America Corp. for the device "WILCOR-XR RP-L MEDICAL FILM". The FDA issued a decision of Substantially Equivalent on March 5, 1984. The device falls under product code IWZ (Film, Radiographic), a Class I device regulated under 21 CFR 892.1840. Cea America Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1984
Date Received
December 20, 1983
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 Cea America Corp.

  • K942525 — MEDICOUNT DEKA HEMATOLOGY ANALYZER (June 5, 1996)
  • K834613 — WILCOR-XR RP MEDICAL FILM (March 5, 1984)
  • K834612 — WILCOR-XR RP-OG MEDICAL FILM (February 27, 1984)
  • K834611 — SINGUL-XR RP NON SCREEN MED. FILM (February 21, 1984)

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)
  • K844554 — BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG (February 21, 1985)

FDA data resources