SDMO APPLICATOR CODE: ASN.8236— 510(k) K921961

Name: FDA 510(k) clearance K921961
Creator: U.S. Food and Drug Administration
Published: 1992-07-01

Substantially Equivalent

Medi-Physics Inc. Dba Nycomed Amersham Imaging

FDA 510(k) clearance K921961 for SDMO APPLICATOR CODE: ASN.8236, Substantially Equivalent on 1992-07-01. Applicant: Medi-Physics Inc. Dba Nycomed Amersham Imaging. Device class: 1.

Clearance details

Applicant: Medi-Physics Inc. Dba Nycomed Amersham Imaging
Product code: Code IWJ
Device class: Class 1
Regulation: 21 CFR 892.5650
Advisory panel: Radiology
Date received: 1992-04-27
Decision date: 1992-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWJ

view all

K010166 — IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM2001-12-03
K980997 — PGK DEVICE (MODIFIED)1998-09-28
K972554 — REGANES RADIONUCLIDE SEED MAGAZINE1998-02-17
K973037 — N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-10001998-01-27
K974118 — WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET1998-01-23

More clearances from Medi-Physics Inc. Dba Nycomed Amersham Imaging

view all

K010821 — ECHOSEED/IODINE-125 SEEDS, MODEL 67332001-04-11
K940632 — I-125 RAPID STRAND1994-09-02
K915156 — I-125 SEEDS CODE: 67021992-01-06
K914268 — I-125 SEEDS IN CARRIER, CODE: 67201991-11-22
K914281 — I-125 SEEDS, CODE: 67111991-11-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.