MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28
FDA 510(k) clearance K915657 · decided 1992-03-13
Clearance details
- K-number
- K915657
- Device name
- MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28
- Applicant
- Bruker Medical Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-18
- Decision date
- 1992-03-13
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Billerica, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.