Elucid PlaqueIQ
Elucid Bioimaging, Inc. · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Boston
- Advisory committee description
- Radiology
- Address 1
- 399 Boylston St., Suite 400
- Statement or summary
- Summary
- Product code
- LLZ
- Zip code
- 02116
- Applicant
- Elucid Bioimaging, Inc.
- Decision date
- 2026-09-18
- Decision code
- SESE
- Country code
- US
- Device name
- Elucid PlaqueIQ
- Advisory committee
- RA
- Contact
- Hiral Vora
- K number
- K261855
- State
- MA
- Date received
- 2026-06-03
- Review advisory committee
- RA
- Postal code
- 02116
- 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
- 3006611212, 3010687441, 8022257, 3011706018, 3007137598, 3023003446, 3006738448, 3006123366, 9612330, 3027158439, 1000432246, 3013283620, 3012391689, 3018133052, 3008364043, 1825014, 3015612252, 3014343888, 1054415, 9680497, 3014232555, 3019216, 3013427569, 3005517190, 3012322232, 3014146081, 3015536273, 3012761544, 3002808157, 3030179922, 3005202320, 3005916315, 3004504920, 3005930550, 3011114764, 1226773, 3038187462, 3007120336, 3000237660, 3010656400 +596 more
- FEI number
- 3006611212, 3010687441, 3011706018, 3007137598, 3023003446, 3002807692, 3006738448, 3003714383, 3006123366, 3027158439, 3002087856, 1000432246, 3002807880, 3013283620, 3012391689, 3018133052, 3008364043, 1825014, 3015612252, 3014343888, 3014232555, 3003190524, 3019216, 3013427569, 3005517190, 3012322232, 3004571294, 3014146081, 1000139922, 3015536273, 3002626007, 3012761544, 3002808157, 3030179922, 3005202320, 3005916315, 3004504920, 3005930550, 3011114764, 3038187462 +596 more