I-View®
Hologic, Inc. · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Newark
- Advisory committee description
- Radiology
- Address 1
- 600 Technology Dr.
- Statement or summary
- Summary
- Product code
- MUE
- Zip code
- 19702
- Applicant
- Hologic, Inc.
- Decision date
- 2026-09-02
- Decision code
- SESE
- Country code
- US
- Device name
- I-View®
- Advisory committee
- RA
- Contact
- Manuela Restrepo Parra
- K number
- K254090
- State
- DE
- Date received
- 2025-12-19
- Review advisory committee
- RA
- Postal code
- 19702
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Full Field Digital, System, X-Ray, Mammographic
- Medical specialty description
- Radiology
- Regulation number
- 892.1715
- Device class
- 2
- Registration number
- 3001556265, 3004977335, 3005406110, 3003769120, 3008833258, 1317307, 3023003446, 1423253, 3010703925, 3005843418, 3005877899, 3009868110, 3009048384, 9613152, 3017585294, 3009717300, 8043728, 3005172103, 3012127758, 3027339477, 3001722928, 3008496839, 2433615, 3008787461, 9680027, 3004485675, 9611343, 3003768251, 3000126629, 3009196578, 3008355361, 3015276088, 3010398867, 3017375271, 3035950510, 3003775006, 3021059265, 3005496266, 3005810333, 3025442726 +3 more
- FEI number
- 3002807903, 3001556265, 3004977335, 3005406110, 3003769120, 3008833258, 1317307, 3023003446, 3010703925, 3005843418, 3005877899, 3009868110, 3009048384, 3017585294, 1000284313, 3009717300, 3005172103, 3012127758, 3027339477, 3002807317, 3001722928, 3008496839, 2433615, 3008787461, 3004485675, 3003768251, 3000126629, 3009196578, 3008355361, 3015276088, 3010398867, 3017375271, 3035950510, 3003775006, 1000514697, 3021059265, 3003772616, 3005810333, 3005496266, 3025442726 +3 more