DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION— 510(k) K950608

Name: FDA 510(k) clearance K950608
Creator: U.S. Food and Drug Administration
Published: 1995-03-02

Substantially Equivalent

Lorad Corp.

FDA 510(k) clearance K950608 for DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION, Substantially Equivalent on 1995-03-02. Applicant: Lorad Corp.. Device class: 2.

Clearance details

Applicant: Lorad Corp.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1995-02-09
Decision date: 1995-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZH

view all

K203509 — SMART FINDER2021-07-14
K202294 — Affirm Contrast Biopsy2020-10-05
K191495 — Biopsy Positioner2019-07-03
K161575 — Affirm Lateral Arm Upright Biopsy Accessory2016-08-10
K161920 — Comfort Cover2016-07-15

More clearances from Lorad Corp.

view all

K992280 — LORAD 1-650 (INTERNATIONAL 650)1999-09-03
K974460 — LITE TOUCH ERBIUM LASER TREATMENT SYSTEM1998-01-16
K973631 — LORAD M-III ELITE (M-III E)1997-12-23
K952210 — LORAD STEROLOC II1995-07-24
K945241 — LORAD M-IV, LORAD M-IVI1995-03-31

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