DELTA 32; DELTA 32 TACT— 510(k) K022275

Name: FDA 510(k) clearance K022275
Creator: U.S. Food and Drug Administration
Published: 2002-09-12

Substantially Equivalent

Instrumentarium Corp. Imaging Division

FDA 510(k) clearance K022275 for DELTA 32; DELTA 32 TACT, Substantially Equivalent on 2002-09-12. Applicant: Instrumentarium Corp. Imaging Division. Device class: 2.

Clearance details

Applicant: Instrumentarium Corp. Imaging Division
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2002-07-15
Decision date: 2002-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, 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 Instrumentarium Corp. Imaging Division

view all

K043612 — ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D2005-02-09
K023864 — PERFORMA STEREO2003-01-09

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