LUMYS (V1)
Intradys · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Brest
- Advisory committee description
- Radiology
- Address 1
- 37 Rue Jean Marie Le Bris
- Statement or summary
- Summary
- Product code
- LLZ
- Zip code
- 29200
- Applicant
- Intradys
- Decision date
- 2025-05-02
- Decision code
- SESE
- Country code
- FR
- Device name
- LUMYS (V1)
- Advisory committee
- RA
- Contact
- Tiffany VAZ
- K number
- K243069
- Date received
- 2024-09-27
- Review advisory committee
- RA
- Postal code
- 29200
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- System, Image Processing, Radiological
- Medical specialty description
- Radiology
- Regulation number
- 892.2050
- Device class
- 2
- Registration number
- 3007697958, 3004009431, 3018405359, 9615916, 3006172536, 3013660213, 3012322232, 3038187462, 3010111497, 3007137598, 3032014234, 2518586, 3015200693, 1836549, 3026309987, 3010728558, 3011713193, 3010331645, 3011713200, 3007120336, 3015537315, 3007993775, 3014954414, 3005075696, 3006115340, 3003898228, 3019269298, 3014809646, 3008364043, 3033525986, 3014262693, 3032579549, 3014483751, 3005180920, 3011015597, 3014146081, 3015158050, 3044519982, 3013077751, 3016438694 +600 more
- FEI number
- 3007697958, 3004009431, 3018405359, 3006172536, 3013660213, 3012322232, 3038187462, 3010111497, 3007137598, 3032014234, 2518586, 3015200693, 3026309987, 3010728558, 3011713193, 3010331645, 3011713200, 3007120336, 3015537315, 3007993775, 3014954414, 3005075696, 3006115340, 3003898228, 7695, 3019269298, 3014809646, 3008364043, 3033525986, 3014262693, 3032579549, 3014483751, 3005180920, 3011015597, 3014146081, 3015158050, 3044519982, 3013077751, 3016438694, 3030982377 +600 more