4DM
INVIA, LLC · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Ann Arbor
- Advisory committee description
- Radiology
- Address 1
- 3025 Boardwalk Dr., Suite 200
- Statement or summary
- Summary
- Product code
- QIH
- Zip code
- 48108
- Applicant
- INVIA, LLC
- Decision date
- 2026-09-10
- Decision code
- SESE
- Country code
- US
- Device name
- 4DM
- Advisory committee
- RA
- Contact
- Edward Ficaro
- K number
- K260879
- State
- MI
- Date received
- 2026-03-17
- Review advisory committee
- RA
- Postal code
- 48108
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Automated Radiological Image Processing Software
- Medical specialty description
- Radiology
- Regulation number
- 892.2050
- Device class
- 2
- Registration number
- 8043836, 3019844085, 3016461002, 8022257, 3013410552, 3019541896, 3033527283, 3008693672, 3013552417, 3017210169, 3003594449, 1000432246, 9710090, 3020928588, 9616047, 3040335643, 3015516266, 9617277, 3030655434, 3010952312, 3001722928, 3015612252, 3042243683, 3038177848, 3042902406, 3007630531, 3033508292, 3019216, 3015425142, 3017167291, 3012981490, 3010885402, 3029915548, 3017426576, 3045078825, 3014146081, 3025110425, 3042248552, 9616251, 2936485 +197 more
- FEI number
- 3019844085, 3016461002, 3013410552, 3019541896, 3002807692, 3003309342, 3033527283, 3008693672, 3002087856, 3010289997, 3013552417, 3003594449, 3017210169, 1000432246, 3002807880, 3020928588, 3040335643, 3015516266, 3030655434, 3007630531, 3010952312, 3001722928, 3015612252, 3042243683, 3038177848, 3042902406, 3003190524, 3033508292, 3019216, 3015425142, 3017167291, 3012981490, 3010885402, 3029915548, 3017426576, 3045078825, 3014146081, 3025110425, 3042248552, 2936485 +197 more