ACUSON NEEDLE GUIDE SYSTEM
FDA 510(k) clearance K854429 · decided 1986-02-07
Clearance details
- K-number
- K854429
- Device name
- ACUSON NEEDLE GUIDE SYSTEM
- Applicant
- Acuson Computed Sonography
- Decision
- Substantially Equivalent
- Date received
- 1985-11-05
- Decision date
- 1986-02-07
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.