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510(k) K913478

RADIOGRAPHIC FILM MARKING SYSTEM by Lorad Medical Systems, Inc. — Product Code JAC

K913478 is an FDA 510(k) premarket notification submitted by Lorad Medical Systems, Inc. for the device "RADIOGRAPHIC FILM MARKING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 15, 1991. The device falls under product code JAC (System, X-Ray, Film Marking, Radiographic), a Class I device regulated under 21 CFR 892.1640. Lorad Medical Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1991
Date Received
August 6, 1991
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 Lorad Medical Systems, Inc.

  • K921962 — LORAD DIGITAL SPOT MAMMOGRAPHY (November 23, 1992)
  • K922619 — DIGITIZER, MODEL # 3-000A-1518 (July 1, 1992)
  • K913732 — MAMMOGRAPHIC X-RAY SYSTEM (February 3, 1992)
  • K894935 — S-70 PORTABLE DENTAL X-RAY SYSTEM (April 25, 1990)
  • K894643 — RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT (December 14, 1989)
  • K882875 — STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY (November 7, 1988)
  • K842102 — LORAD (July 17, 1984)

Other clearances for product code JAC

  • K942883 — DIGITAL I.D. CAMERA (September 30, 1994)
  • K930752 — CT/MRI TOPOGRAPHIC MARKER (November 19, 1993)
  • 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)

FDA data resources