MODIFICATION TO FOCUS— 510(k) K022630

Substantially Equivalent

Instrumentarium Corp.

FDA 510(k) clearance K022630 for MODIFICATION TO FOCUS, Substantially Equivalent on 2002-10-09. Applicant: Instrumentarium Corp.. Device class: 2.

Clearance details

Applicant: Instrumentarium Corp.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2002-08-07
Decision date: 2002-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Instrumentarium Corp.

K001729 — FOCUS2000-07-13
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K981641 — MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ1998-07-17
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Recalls naming K022630

K-number listed on FDA's recall record

Z-1091-2014 — The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.Class II·Terminated·Instrumentarium Dental, PaloDEx Group Oy·20140114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022630.

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