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510(k) K012373

LIFERAY WL CASSETTE, LIFERAY KW CASSETTE by Ferrania S.P.A. — Product Code IXA

K012373 is an FDA 510(k) premarket notification submitted by Ferrania S.P.A. for the device "LIFERAY WL CASSETTE, LIFERAY KW CASSETTE". The FDA issued a decision of Substantially Equivalent on August 9, 2001. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Ferrania S.P.A. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2001
Date Received
July 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type

Other clearances by Ferrania S.P.A.

  • K013395 — LIFEJET VIDEO LINK (October 30, 2001)

Other clearances for product code IXA

  • K081557 — PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER (September 10, 2008)
  • K053173 — DS CASSETTE (December 15, 2005)
  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)
  • K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX (September 26, 2002)
  • K021903 — KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE (July 10, 2002)
  • K013686 — KODAK DIRECTVIEW TABLETOP CASSETTE (December 7, 2001)
  • K013229 — LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE (October 12, 2001)
  • K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (March 12, 1999)
  • K980722 — TRIMAX RADIOGRAPHIC CASSETTE (March 23, 1998)
  • K963914 — CM & CM DS-7 (October 8, 1997)

FDA data resources