NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
Siemens Medical Solutions USA, Inc. · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Knoxville
- Advisory committee description
- Radiology
- Address 1
- 810 Innovation Dr.
- Statement or summary
- Summary
- Product code
- JAK
- Zip code
- 37932
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision date
- 2025-02-12
- Decision code
- SESE
- Country code
- US
- Device name
- NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
- Advisory committee
- RA
- Contact
- Tabitha Estes
- K number
- K243523
- State
- TN
- Date received
- 2024-11-14
- Review advisory committee
- RA
- Postal code
- 37932
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- System, X-Ray, Tomography, Computed
- Medical specialty description
- Radiology
- Regulation number
- 892.1750
- Device class
- 2
- Registration number
- 3007225492, 3027338963, 3018094310, 9617978, 3015223550, 3018423337, 3002807636, 3015169361, 3010703925, 3003768277, 3029521953, 1066019, 3017375271, 3009154005, 3004962788, 9616567, 3004091527, 3012957335, 3010398867, 3016965352, 2247992, 3003575350, 3002808157, 1054713, 3006209933, 3004857110, 3008114965, 3026047529, 3043512431, 3003477135, 3008284470, 3009196578, 3031503890, 1000246715, 3019216, 3001722928, 3013679558, 3004753774, 3005156333, 3011015597 +125 more
- FEI number
- 3007225492, 3027338963, 3018094310, 3015223550, 3018423337, 3002807636, 3015169361, 3010703925, 3002807903, 3008581796, 3029521953, 3003079232, 1000139922, 3017375271, 3009154005, 3004962788, 3004091527, 3012957335, 3010398867, 3016965352, 3003575350, 3002808157, 3002808529, 3002808382, 1000123143, 3006209933, 3004857110, 3008114965, 3026047529, 3043512431, 3003477135, 3008284470, 3009196578, 3000206435, 3031503890, 1000246715, 3019216, 3001722928, 3013679558, 3004753774 +125 more