# K973206: Sterling Diagnostic Imaging Direct Radiography

- Pathway: 510(k) (Traditional)
- Applicant: Sterling Diagnostic Imaging, Inc.
- Decided: Dec 4, 1997 after 100 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
No predicates in its family tree.
153 later devices descend from it; 5 cite it directly.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Conventional screen-film systems: named in the summary without a submission number

## Most influential descendants
- K982795: Philips Bucky Vision (1998), 141 descendants of its own
- K992794: Stingray DR, Model 1 (1999), 103 descendants of its own
- K024147: Paxscan 4030 Medical Digital Imaging System (2003), 78 descendants of its own
- K090625: Wireless Portable Detector FD-W17 (2009), 41 descendants of its own
- K092669: DX-D Imaging Package (2009), 34 descendants of its own

## Indications for use
The Direct Radiography™ device provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

Source page: https://510kreport.com/device/K973206
Methodology: https://510kreport.com/methodology