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510(k) K974423

ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL by Sterling Diagnostic Imaging, Inc. — Product Code EAM

K974423 is an FDA 510(k) premarket notification submitted by Sterling Diagnostic Imaging, Inc. for the device "ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL". The FDA issued a decision of Substantially Equivalent on December 22, 1997. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. Sterling Diagnostic Imaging, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1997
Date Received
November 24, 1997
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 Sterling Diagnostic Imaging, Inc.

  • K980970 — IIRAD DIRECTRAY OPERATOR CONSOLE (June 8, 1998)
  • K980220 — IISYS PACS SYSTEM (February 13, 1998)
  • K973206 — STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY (December 4, 1997)
  • K972660 — RAVEN DRY PRINTER (November 10, 1997)
  • K973028 — HELIOS LASER IMAGER 1417 (October 28, 1997)
  • K964250 — LINX NETWORKING SYSTEM (December 18, 1996)

Other clearances for product code EAM

  • K963913 — MD100 & MM150 (October 8, 1997)
  • K954161 — JPI INTENSIFYING SCREEN (February 2, 1996)
  • K943823 — FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 (August 22, 1994)
  • K943821 — KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC (August 22, 1994)
  • K943822 — FUJI UM MAMMO SERIES INTENSIFY SCREENS: (August 22, 1994)
  • K942235 — KYOKKO GREEN SERIES INTENSIFYING SCREENS (August 17, 1994)
  • K943425 — FUJI HG-M INTENSIFYING SCREEN (August 17, 1994)
  • K942909 — KODAK INSIGHT TWIN-LOAD INSERT (July 29, 1994)
  • K942805 — KYOKKO BLUE SERIES INTENSIFYING SCREENS (July 29, 1994)
  • K942399 — KYOKKO UM SERIES INTENSIFYING SCREEN (June 10, 1994)

FDA data resources