# K022630: Modification to Focus

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Corp.
- Decided: Oct 9, 2002 after 63 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001729 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001729: FOCUS, Instrumentarium Corp. (2000)

## Recalls of this device
- Jan 14, 2014 · Class II · Z-1091-2014: Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a potential flaw in the mounting hardware. A number of wall mount units were delivered with FOCUS

## Indications for use
Focus is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

Source page: https://510kreport.com/device/K022630
Methodology: https://510kreport.com/methodology