Submission Details
| 510(k) Number | K022630 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 07, 2002 |
| Decision Date | October 09, 2002 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
MODIFICATION TO FOCUS
Oct 2002
Decision
63d
Days
Class 2
Risk
About This 510(k) Submission
K022630 is an FDA 510(k) clearance for the MODIFICATION TO FOCUS, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Instrumentarium Corp. (Milwaukee, US). The FDA issued a Cleared decision on October 9, 2002, 63 days after receiving the submission on August 7, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.
Device Classification
| Product Code | EHD — Unit, X-ray, Extraoral With Timer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.1800 |
Manufacturer
Similar Devices — EHD Unit, X-ray, Extraoral With Timer
All 187
K252110 · Guangzhou Ajax Medical Equipment Co., Ltd.
· Mar 2026
K254018 · Guilin Refine Medical Instrument Co., Ltd.
· Feb 2026
K252909 · Ningbo Runyes Medical Instrument Co., Ltd.
· Feb 2026
K251438 · Guilin Woodpecker Medical Instrument Co., Ltd.
· Sep 2025
K242185 · Raypia Co., Ltd.
· Dec 2024
K242591 · DRTECH Corporation
· Nov 2024
More from Instrumentarium Corp.
View all
K001729
· EHD · Jul 2000
K001439
· MUH · Jun 2000
K992385
· MUH · Sep 1999
K981641
· IZH · Jul 1998
K962638
· CCK · Apr 1997