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510(k) K925892

SOLSTICE XRAY RING MARKER PAD by Solstice Corp. — Product Code JAC

K925892 is an FDA 510(k) premarket notification submitted by Solstice Corp. for the device "SOLSTICE XRAY RING MARKER PAD". The FDA issued a decision of Substantially Equivalent on May 18, 1993. The device falls under product code JAC (System, X-Ray, Film Marking, Radiographic), a Class I device regulated under 21 CFR 892.1640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1993
Date Received
November 17, 1992
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 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)
  • 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