Home / 510(k) Clearances / K933161

510(k) K933161

ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN by Dupont Medical Products — Product Code EAM

K933161 is an FDA 510(k) premarket notification submitted by Dupont Medical Products for the device "ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN". The FDA issued a decision of Substantially Equivalent on October 7, 1993. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. Dupont Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1993
Date Received
June 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screen, Intensifying, Radiographic
Device Class
Class I
Regulation Number
892.1960
Review Panel
RA
Submission Type

Other clearances by Dupont Medical Products

  • K952815 — DUPONT LIPASE CALIBRATOR (August 31, 1995)
  • K950920 — DUPONT DIMENSION TOTAL PROTEIN METHOD (August 11, 1995)
  • K952816 — LIPASE FLEX REAGENT CARTRIDGE (July 20, 1995)
  • K952412 — DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL (June 23, 1995)
  • K945280 — DUPONT DIMENSION C-REACTIVE PROTEIN METHOD (March 9, 1995)
  • K944932 — PHENOBARBITAL FLEX REAGENT CARTRIDGE (December 28, 1994)
  • K941050 — DUPONT ACA STAR (November 10, 1994)
  • K943996 — DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD (October 20, 1994)
  • K941146 — DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM (October 3, 1994)
  • K942640 — DUPONT DIMENSION AMYLASE METHOD (September 9, 1994)

Other clearances for product code EAM

  • K974423 — ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL (December 22, 1997)
  • K963913 — MD100 & MM150 (October 8, 1997)
  • K954161 — JPI INTENSIFYING SCREEN (February 2, 1996)
  • K943821 — KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC (August 22, 1994)
  • K943822 — FUJI UM MAMMO SERIES INTENSIFY SCREENS: (August 22, 1994)
  • K943823 — FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 (August 22, 1994)
  • K943425 — FUJI HG-M INTENSIFYING SCREEN (August 17, 1994)
  • K942235 — KYOKKO GREEN SERIES INTENSIFYING SCREENS (August 17, 1994)
  • K942805 — KYOKKO BLUE SERIES INTENSIFYING SCREENS (July 29, 1994)
  • K942909 — KODAK INSIGHT TWIN-LOAD INSERT (July 29, 1994)

FDA data resources