MD100 & MM150— 510(k) K963913

Substantially Equivalent

Konica Medical Corp.

FDA 510(k) clearance K963913 for MD100 & MM150, Substantially Equivalent on 1997-10-08. Applicant: Konica Medical Corp.. Device class: 1.

Clearance details

Applicant: Konica Medical Corp.
Product code: Code EAM
Device class: Class 1
Regulation: 21 CFR 892.1960
Advisory panel: Radiology
Date received: 1996-09-30
Decision date: 1997-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EAM

K974423 — ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL1997-12-22
K954161 — JPI INTENSIFYING SCREEN1996-02-02
K943821 — KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC1994-08-22
K943822 — FUJI UM MAMMO SERIES INTENSIFY SCREENS:1994-08-22
K943823 — FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-121994-08-22

More clearances from Konica Medical Corp.

K990969 — KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR1999-06-18
K963914 — CM & CM DS-71997-10-08
K955583 — VIFS1996-05-14
K931315 — KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR1993-12-14
K931316 — KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR1993-12-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.