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510(k) K940632

I-125 RAPID STRAND by Medi-Physics Inc. Dba Nycomed Amersham Imaging — Product Code IWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1994
Date Received
February 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Isotope, Sealed, Gold, Titanium, Platinum
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Medi-Physics Inc. Dba Nycomed Amersham Imaging

  • K010821 — ECHOSEED/IODINE-125 SEEDS, MODEL 6733 (April 11, 2001)
  • K921961 — SDMO APPLICATOR CODE: ASN.8236 (July 1, 1992)
  • K915156 — I-125 SEEDS CODE: 6702 (January 6, 1992)
  • K914281 — I-125 SEEDS, CODE: 6711 (November 22, 1991)
  • K914268 — I-125 SEEDS IN CARRIER, CODE: 6720 (November 22, 1991)
  • K811688 — TUNGSTEN SYRINGE SHIELD (July 2, 1981)
  • K811677 — KRYPTON CART (July 2, 1981)
  • K811118 — KRYPTON MASKS & TUBING (June 2, 1981)

Other clearances for product code IWI

  • K973363 — NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL ME (July 2, 1998)
  • K912170 — RADIOACTIVE IODINE-125 SOURCES (August 9, 1991)
  • K882449 — CESIUM 137 SOURCE, MODEL CSM-40 (April 14, 1989)
  • K874787 — MODIFIED PALLADIUM SEED MODEL 100 (December 22, 1987)
  • K852542 — PALLADIUM SEED MODEL 100 (January 14, 1986)