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510(k) K921961

SDMO APPLICATOR CODE: ASN.8236 by Medi-Physics Inc. Dba Nycomed Amersham Imaging — Product Code IWJ

K921961 is an FDA 510(k) premarket notification submitted by Medi-Physics Inc. Dba Nycomed Amersham Imaging for the device "SDMO APPLICATOR CODE: ASN.8236". The FDA issued a decision of Substantially Equivalent on July 1, 1992. The device falls under product code IWJ (System, Applicator, Radionuclide, Manual), a Class I device regulated under 21 CFR 892.5650. Medi-Physics Inc. Dba Nycomed Amersham Imaging has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1992
Date Received
April 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Manual
Device Class
Class I
Regulation Number
892.5650
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)
  • K940632 — I-125 RAPID STRAND (September 2, 1994)
  • 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 IWJ

  • K010166 — IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (December 3, 2001)
  • K980997 — PGK DEVICE (MODIFIED) (September 28, 1998)
  • K972554 — REGANES RADIONUCLIDE SEED MAGAZINE (February 17, 1998)
  • K973037 — N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 (January 27, 1998)
  • K974118 — WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET (January 23, 1998)
  • K973786 — NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE (January 2, 1998)
  • K973638 — N.I.T., INC. NEEDLE GUIDING TEMPLATE (December 23, 1997)
  • K973184 — PROSTATE SEEDING NEEDLE (November 21, 1997)
  • K963743 — MANAN PROSTATE UNI-LOCK (December 6, 1996)
  • K951052 — WEEKS APPLICATOR (August 22, 1996)

FDA data resources