APERTO Lucent MRI System
FUJIFILM Healthcare Americas Corporation · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Lexington
- Advisory committee description
- Radiology
- Address 1
- 81 Hartwell Ave.
- Address 2
- Suite 300
- Statement or summary
- Summary
- Product code
- LNH
- Zip code
- 02421
- Applicant
- FUJIFILM Healthcare Americas Corporation
- Decision date
- 2024-05-10
- Decision code
- SESE
- Country code
- US
- Device name
- APERTO Lucent MRI System
- Advisory committee
- RA
- Contact
- Duan Threats
- K number
- K233629
- State
- MA
- Date received
- 2023-11-13
- Review advisory committee
- RA
- Postal code
- 02421
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- System, Nuclear Magnetic Resonance Imaging
- Medical specialty description
- Radiology
- Regulation number
- 892.1000
- Device class
- 2
- Registration number
- 3014635027, 3018094310, 3015223550, 3018423337, 3010326005, 1650907, 3010703925, 3003768277, 3029521953, 3014310698, 3017375271, 3014232555, 3009154005, 3033333119, 3010398867, 2247992, 3023385454, 3006369484, 3002808157, 3010009632, 1054713, 3006015847, 3011657336, 3026047529, 3008284470, 3009196578, 3013343065, 3009755250, 3031503890, 3042177665, 3013679558, 3018004899, 3009714754, 3011015597, 3006239787, 3026391023, 3004977335, 2126677, 3019844073, 3004526608 +110 more
- FEI number
- 3014635027, 3018094310, 3005214683, 3015223550, 3018423337, 3010326005, 3010703925, 3029521953, 3014310698, 3017375271, 3014232555, 3009154005, 1000571342, 3033333119, 3010398867, 3003377038, 3023385454, 3006369484, 3002808157, 3010009632, 3002808382, 3006015847, 3011657336, 3026047529, 3008284470, 3009196578, 3013343065, 1937223, 3009755250, 3031503890, 3042177665, 3013679558, 3018004899, 3009714754, 3011015597, 1000138054, 3006239787, 3026391023, 3004977335, 2126677 +110 more