Home / 510(k) Clearances / K930752

510(k) K930752

CT/MRI TOPOGRAPHIC MARKER by I.Z.I. Corp. — Product Code JAC

K930752 is an FDA 510(k) premarket notification submitted by I.Z.I. Corp. for the device "CT/MRI TOPOGRAPHIC MARKER". The FDA issued a decision of Substantially Equivalent on November 19, 1993. The device falls under product code JAC (System, X-Ray, Film Marking, Radiographic), a Class I device regulated under 21 CFR 892.1640. I.Z.I. Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1993
Date Received
February 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Film Marking, Radiographic
Device Class
Class I
Regulation Number
892.1640
Review Panel
RA
Submission Type

Other clearances by I.Z.I. Corp.

  • K022074 — SPHERZ (August 13, 2002)
  • K014022 — MRI LINE MARKER (March 4, 2002)
  • K003736 — MRI LINE MARKER (January 18, 2001)
  • K994117 — MR ENHANCER (February 4, 2000)
  • K993742 — SUPER TISSUE (February 2, 2000)
  • K922287 — E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS (October 16, 1992)

Other clearances for product code JAC

  • K942883 — DIGITAL I.D. CAMERA (September 30, 1994)
  • K932357 — FUJI EC ID CAMERA (July 26, 1993)
  • K925892 — SOLSTICE XRAY RING MARKER PAD (May 18, 1993)
  • K923533 — ADMARK (March 4, 1993)
  • K926404 — KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L (March 4, 1993)
  • K925332 — BENNETT X-RAY ID PLUS (November 27, 1992)
  • K924345 — RADIOGRAPHIC FILM MARKETING SYSTEM (November 27, 1992)
  • K920031 — KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE (February 12, 1992)
  • K915088 — KODAK MIN-R IDENTIFICATION CAMERA (December 2, 1991)
  • K913478 — RADIOGRAPHIC FILM MARKING SYSTEM (October 15, 1991)

FDA data resources