Dental Imaging Technologies Corporation · Class II · Cleared Mar 20, 2026
| K-number | K253864 |
| Device name | NOMAD Pro 3 |
| Applicant | Dental Imaging Technologies Corporation |
| Product code | EHD |
| Device class | Class II |
| Decision date | Mar 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.1800 |
The NOMAD Pro 3 is a battery-operated, handheld dental X-ray system designed for extraoral diagnostic imaging using intraoral image receptors (film, digital sensors, or phosphor plates). It is intended for use by trained dentists or dental technicians on both adult and pediatric patients in dental offices and similar settings.
The device uses a fixed 65 kV tube voltage and 2.5 mA tube current with operator-adjustable exposure time (0.04–1.0 seconds). Key differences from the predicate include slightly increased weight (6.4 lbs vs. 6.0 lbs), modified dimensions, increased kVp (65 kVp vs. 60 kVp), optional bismuth-acrylic or lead-acrylic backscatter shields, and an analog control system replacing the predicate's programmable logic device. Battery specifications (1.7 A-Hr, 70% capacity retention after 300 cycles) and source-to-skin distance (21 cm) remain identical.
ISO 14971, IEC 62366-1, IEC 60601-1-6, ISO 10993-1/5/10/12/23, IEC 60601-1-3, IEC 60601-2-65, IEC 60601-1, IEC 60601-1-2, IEC 62304, and ANSI AAMI ES60601-1:2005.
View the full FDA submission: accessdata.fda.gov