# K093790: Simondr DRP

- Pathway: 510(k) (Traditional)
- Applicant: Simondr, Inc.
- Decided: Apr 5, 2010 after 116 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K981556 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091435: Digital Radiography Model Cxdi-55G, Canon, Inc. (2009). Our OCR of the scanned summary read K091345, FDA’s number for Gopher Gold Catheter, Model 5620 (Vascular Solutions, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Canon CXDI-55G”.
- (no number) Kodak (Carestream) Lanex Screen/AGFA Y2 Speed Film: named in the summary without a submission number

## Indications for use
The Models SimonDR DRP Digital X-Ray Imager is a digital x-ray Imager intended for physicians or technologists operating under the guidance of the physician, to use for diagnostic x-ray imaging in podiatric practices instead of using a film based system.

Source page: https://510kreport.com/device/K093790
Methodology: https://510kreport.com/methodology