# K202664: Clio Prime and Clio Pedo

- Pathway: 510(k) (Traditional)
- Applicant: Sota Precision Optics, Inc. Dba Sota Imaging
- Decided: Nov 6, 2020 after 53 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: 4 generations back to K933455 (1994). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090458: Dexis Sensor, Dexis, LLC (2009) Summary page 5.

## Most influential descendants
- K221955: Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 (2022), 1 descendant of its own
- K241649: DUO1 and DUO2 (2024), 0 descendants of its own

## Indications for use
Clio Prime and Clio Pedo are USB-driven, digital intraoral x-ray sensors which are intended to acquire dental intraoral radiography images. Clio Prime or Clio Pedo shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs. Clio Prime or Clio Pedo can be used either in combination with special positioning devices to facilitate positioning and alignment with an x-ray beam, or Clio Prime or Clio Pedo can also be positioned by hand with the assistance of the patient.

Source page: https://510kreport.com/device/K202664
Methodology: https://510kreport.com/methodology