Vatech's Green X 21 Combines Several Imaging Modes. Audit Its Touchpoints.

What was cleared

VATECH's Green X 21 (model PHT-90CHO) is a combined X-ray system. According to the FDA 510(k) record, the decision was "substantially equivalent" on February 14, 2025 (K243081). The intended use is panoramic, cephalometric or 3D digital X-ray images of the dento-maxillofacial, sinus, TMJ and ENT regions in adult and paediatric patients. The record lists six modalities: Pano, Ceph (optional), Dental CT, ENT CT, Model and Face Scan. Face Scan overlays 3D photographs onto the CT images and uses no X-ray.

A retailer listing describes the same unit as "5 in 1" and lists selectable fields of view from 21x19 cm down to 4x4 cm, with a 4x4 cm field for its Endo Mode. The two sources count the modes differently, so treat the number as marketing and look at what your own unit is licensed and configured to do.

What neither source tells you

Neither page says anything about hygiene. The FDA record does not mention a chin rest, bite block or temple supports, and the retailer page does not describe the patient-positioning parts or the control panel. So we cannot tell you which surfaces on this unit need a barrier. Anyone who gives you a definitive list without the manufacturer's instructions for use is guessing.

What we can say is where the general guidance points. A dental hygiene article on radiographic asepsis lists the "X-ray tube head, switches or controls, mouse, keyboard, and digital radiograph sensors" as items to disinfect and/or cover with a plastic barrier. It recommends one-time-use barriers for hard-to-clean items such as switches and exposure buttons, and says that "a combination of barriers and surface disinfection is recommended for radiographic equipment." That article deals with intraoral radiography and does not mention panoramic or CBCT units, so applying it to a combined unit is our extension of the principle, not something it states.

Why a combined unit changes the audit

One chassis serving several workflows means one set of surfaces gets touched in more than one way. A patient who has a panoramic image and then a small-field CT scan meets the positioning parts twice. The operator touches the control panel, the exposure button and the workstation mouse and keyboard for every mode. Nothing here is new in kind, but the number of "which mode touches what" combinations grows.

A Monday-morning check

1. Find the manufacturer's instructions for use and read the cleaning and disinfection section first. That is the authority for your unit.
2. Walk one patient through each mode you actually use. Write down every part a patient or a gloved hand touches.
3. Mark each part as smooth and easy to wipe, or hard to clean (seams, switches, textured grips).
4. For each part choose barrier, disinfection or both, and write it into the room protocol.
5. Check that the barrier or sleeve you stock fits the parts you listed. Fit is specific to the part and the brand.
6. Agree who resets the unit between patients, so the step is not skipped when the schedule is tight.

What stays the same

The Green X 21 does not change the basic rule: surfaces that are touched and hard to clean get a barrier changed between patients, and the rest get disinfected as the instructions allow. If your practice already follows a written radiography protocol, the work is adding the new surfaces to it, not rewriting it.