Home / 510(k) Clearances / K882519

510(k) K882519

X-RAY MARKER by Karlin Technology, Inc. — Product Code JAC

K882519 is an FDA 510(k) premarket notification submitted by Karlin Technology, Inc. for the device "X-RAY MARKER". The FDA issued a decision of Substantially Equivalent on August 9, 1988. The device falls under product code JAC (System, X-Ray, Film Marking, Radiographic), a Class I device regulated under 21 CFR 892.1640. Karlin Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1988
Date Received
June 17, 1988
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 Karlin Technology, Inc.

  • K903969 — SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET (September 5, 1990)
  • K893201 — BONE PLATE (April 4, 1990)
  • K893203 — BONE SCREW (April 4, 1990)
  • K882525 — SPINAL MICROKNIFE (September 22, 1988)
  • K882073 — SPINAL NEEDLE (July 18, 1988)
  • K882520 — SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS (July 18, 1988)
  • K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD (July 8, 1988)
  • K882077 — MICRODISCECTOMY CURRETTES (June 17, 1988)
  • K882069 — SPINAL DISTRACTORS, SPANNERS (June 17, 1988)
  • K882072 — ORTHOPAEDIC AND SPINAL RING CURRETTES (June 17, 1988)

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)
  • K926404 — KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L (March 4, 1993)
  • K923533 — ADMARK (March 4, 1993)
  • K924345 — RADIOGRAPHIC FILM MARKETING SYSTEM (November 27, 1992)
  • K925332 — BENNETT X-RAY ID PLUS (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