Woodpecker Mini Ray Portable Dental X-Ray FDA Cleared Device

Woodpecker Mini Ray is an FDA-cleared portable dental X-ray machine for intraoral radiography. This Class II medical device generates ionizing radiation and requires proper licensing, registration, and safety compliance.

Federal Law Restriction: Federal law restricts this device to sale by or on the order of a licensed dentist.

Radiation Safety: Requires state registration, operator licensing, radiation safety training, and compliance with federal and state radiation control regulations.

Installation: Must be installed by certified X-ray equipment technicians.

FDA Disclaimer: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Key Features

1. FDA cleared portable X-ray system
2. Portable design for mobile dental applications
3. [High-frequency generator - if applicable]
4. Digital radiography compatible
5. Professional dental radiology equipment

Intended Use

FDA-Cleared Indication:

1. Portable dental radiography for intraoral diagnostic imaging by licensed dental professionals.

Clinical Applications:

1. Intraoral dental radiography
2. Portable/mobile dental services
3. Bedside dental imaging
4. Field dental clinics

Intended Users:

1. Licensed dentists only
2. With valid radiation operator license
3. Proper radiation safety training

Regulatory & Safety Requirements

State Requirements:

1. X-ray equipment registration
2. Radiation operator license
3. Annual inspections
4. Radiation safety officer designation
5. Compliance with state radiation control program

Operator Requirements:

1. Licensed dentist
2. Radiation safety certification
3. Continuing education
4. Dosimetry monitoring (if required)

Installation Requirements:

1. Certified X-ray equipment technician
2. Radiation shielding assessment
3. Safety protocol implementation
4. Documentation and record-keeping

Radiation Safety

IONIZING RADIATION EQUIPMENT

Safety Protocols:

1. ALARA principles mandatory
2. Proper collimation
3. Appropriate exposure factors
4. Patient shielding (lead aprons, thyroid collars)
5. Operator positioning (6+ feet or behind barrier)
6. Radiation area signage
7. Controlled area designation

Contraindications:

1. Pregnancy (relative - use clinical judgment)
2. Patients requiring special considerations
3. When diagnostic benefit doesn't outweigh risk

Monitoring:

1. Equipment calibration
2. Quality assurance testing
3. Radiation surveys
4. Dose documentation

Directions for Use

Pre-Use Requirements:

1. Verify state equipment registration current
2. Confirm operator license valid
3. Complete radiation safety training
4. Ensure proper installation and calibration
5. Review safety protocols

During Use:

1. Position patient with appropriate shielding
2. Set correct exposure parameters
3. Position device per technique
4. Clear area of unnecessary personnel
5. Verify proper distance/barrier
6. Activate exposure
7. Follow ALARA principles

Post-Use:

1. Document exposure in patient records
2. Maintain exposure logs
3. Clean and disinfect equipment
4. Store securely
5. Regular maintenance per schedule

Disclaimer

REGULATED MEDICAL DEVICE

FDA-cleared Class II medical device. Federal law restricts sale to licensed dentists. Generates ionizing radiation. Requires state registration, operator licensing, certified installation, and radiation safety compliance. Professional use only in properly equipped facilities. Not for consumer, home, or unlicensed use.

FAQs

1. Is this FDA cleared?

Answer: Yes, FDA cleared [K-number] as Class II portable dental X-ray machine.

2. Who can purchase this?

Answer: Licensed dentists only. Requires proof of professional license, radiation operator certification, and state registration.

3. Can I use this without special licensing?

Answer: No. Requires dental license AND radiation operator license. State X-ray equipment registration mandatory.

4. Does this require installation?

Answer: Yes. Must be installed by certified X-ray equipment technician. Radiation safety assessment required.

5. What training is required?

Answer: Radiation safety training, state-specific X-ray operator certification, continuing education per state requirements.

6. Is state registration required?

Answer: Yes. All X-ray equipment must be registered with state radiation control program before use.

7. What safety equipment is needed?

Answer: Lead aprons, thyroid collars, radiation area signage, dosimetry badges (if required), calibrated equipment.

8. How often are inspections required?

Answer: Annual state inspections typical. Regular equipment calibration and quality assurance testing required.

9. Can I use this for mobile dental services?

Answer: Yes, if properly registered and operated by licensed personnel with appropriate safety protocols for mobile use.

10. How often does this need calibration?

Answer: Annual calibration by certified X-ray service technician is typically required. State regulations may mandate specific intervals. Regular quality assurance testing should be performed per state requirements.