Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
VATECH Co., Ltd. · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Hwaseong-Si
- Advisory committee description
- Radiology
- Address 1
- 13, Samsung 1-Ro 2-Gil
- Statement or summary
- Summary
- Product code
- OAS
- Zip code
- 18449
- Applicant
- VATECH Co., Ltd.
- Decision date
- 2026-03-31
- Decision code
- SESE
- Country code
- KR
- Device name
- Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
- Advisory committee
- RA
- Contact
- Daniel Kim
- K number
- K260093
- Date received
- 2026-01-13
- Review advisory committee
- RA
- Postal code
- 18449
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- X-Ray, Tomography, Computed, Dental
- Medical specialty description
- Radiology
- Regulation number
- 892.1750
- Device class
- 2
- Registration number
- 3012649815, 3045816948, 3010445368, 3009196578, 3005554774, 3031093388, 3004706313, 3014398772, 3009543051, 3012957335, 2024980, 3004884150, 9614977, 3010281549, 9615832, 8043728, 3005383085, 3030898585, 3013510497, 3013511605, 3023322470, 3045129740, 3030089802, 3001052305, 3016875543, 3002807636, 3012494290, 8030876, 1226003, 3005843418, 3003528079, 3015509619, 3021551875, 3031886796, 3002994636, 3005706667, 3011471624, 3018596740, 3006610845, 3009717300 +8 more
- FEI number
- 3012649815, 3045816948, 3010445368, 3008875470, 3009196578, 3005554774, 3031093388, 3002807903, 3004706313, 3014398772, 3009543051, 3012957335, 3004884150, 3010281549, 3002522649, 3005383085, 3030898585, 3013510497, 3013511605, 3023322470, 3003719498, 3045129740, 3030089802, 3001052305, 3016875543, 3002807636, 3012494290, 3005843418, 3003528079, 3015509619, 3021551875, 3031886796, 3002994636, 3005706667, 1000207287, 3011471624, 3003026827, 3006610845, 3009717300, 3018596740 +8 more