XLITE
GEMSS HEALTHCARE CO., LTD. · Radiology
Open FDA's page for this record- Third party flag
- Y
- City
- Paju-Si
- Advisory committee description
- Radiology
- Address 1
- 1f, 822, Bogwang-Ro, Gwangtan-Myeon
- Statement or summary
- Summary
- Product code
- IZL
- Zip code
- 10952
- Applicant
- GEMSS HEALTHCARE CO., LTD.
- Decision date
- 2026-08-03
- Decision code
- SESE
- Country code
- KR
- Device name
- XLITE
- Advisory committee
- RA
- Contact
- Jeongbin Park
- K number
- K260236
- Date received
- 2026-01-26
- Review advisory committee
- RA
- Postal code
- 10952
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- System, X-Ray, Mobile
- Medical specialty description
- Radiology
- Regulation number
- 892.1720
- Device class
- 2
- Registration number
- 3005246977, 3015502499, 3016250464, 3023003446, 3015223550, 9616047, 3018269927, 3021006193, 3001722928, 3006542593, 1225677, 3013679558, 2433615, 3007836437, 3012624817, 3009001657, 3006051164, 3010398867, 3016674851, 3025442726, 3018077344, 3031503890, 3033525986, 3009134655, 3001556265, 3004977335, 3014209556, 3029916061, 9613445, 1219183, 3008284470, 8030233, 3008044777, 1418964, 3008496839, 3010300212, 3007065358, 9617251, 3003768251, 3015276088 +39 more
- FEI number
- 3005246977, 3015502499, 3016250464, 3023003446, 3015223550, 3018269927, 3021006193, 3001722928, 3001451453, 3006542593, 3013679558, 2433615, 3007836437, 3012624817, 3009001657, 3006051164, 3010398867, 3016674851, 3025442726, 3018077344, 3002143662, 3031503890, 3033525986, 3009134655, 3002807605, 3001556265, 3004977335, 3014209556, 3029916061, 1219183, 3008284470, 3008044777, 1418964, 3008496839, 3010300212, 3007065358, 3003768251, 3015276088, 3013677815, 3011416394 +39 more