# K060149: Sunipan Imaging System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Suni Medical Imaging, Inc.
- Decided: Feb 3, 2006 after 14 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K882436 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051664: SCAN300FP / Retropan (VDC), Oy Ajat, Ltd. (2005) Summary page 2.
- K043557: Model PC-1000 Panoramic/Cephalometric X-Ray Systems, Panoramic Corp. (2005) Summary page 2.

## Indications for use
For diagnostic radiographic use in dental, oral surgery, and orthodontic practices

Source page: https://510kreport.com/device/K060149
Methodology: https://510kreport.com/methodology