IR-192 IMPLANT— 510(k) K844248

Substantially Equivalent

Rads S.L., Inc.

FDA 510(k) clearance K844248 for IR-192 IMPLANT, Substantially Equivalent on 1985-04-10. Applicant: Rads S.L., Inc.. Device class: 2.

Clearance details

Applicant: Rads S.L., Inc.
Product code: Code IWA
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1984-11-02
Decision date: 1985-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Charles, LA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWA

K915253 — IR-192 IMPLANT, MODIFICATION1992-02-27
K894409 — CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD1989-09-29
K874895 — IR-192 IMPLANT1988-02-25
K850382 — IRIDIUM SEEDS1985-08-15
K850163 — IRIDIUM 192 WIRES1985-03-26

More clearances from Rads S.L., Inc.

K903465 — IR-192 IMPLANT1990-10-12

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