FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K Number: K041695
·
Decision Jul 23, 2004
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
64
Review Days
31
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Basic Information
- Device Name
- LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
- K Number
- K041695
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Usa Instruments, Inc.
- Date Received
- June 22, 2004
- Decision Date
- July 23, 2004
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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Other Clearances by Usa Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052916 | USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY | Nov 9, 2005 | Substantially Equivalent |
| K052621 | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL | Oct 7, 2005 | Substantially Equivalent |
| K052584 | 1.5T 12 CHANNEL BODY ARRAY | Oct 7, 2005 | Substantially Equivalent |
| K052585 | 3T HD BREAST ARRAY | Oct 4, 2005 | Substantially Equivalent |
| K050728 | OPEN BREAST COIL (OBC) WITH BIOPSY PLATES | Jun 28, 2005 | Substantially Equivalent |
| K042342 | MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL | Sep 24, 2004 | Substantially Equivalent |
| K042186 | 3.0T 8-CHANNEL CTL SPINE ARRAY | Aug 26, 2004 | Substantially Equivalent |
| K042207 | 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL | Aug 26, 2004 | Substantially Equivalent |
| K042009 | MARK III PHASED ARRAY SHOULDER COIL | Aug 11, 2004 | Substantially Equivalent |
| K041487 | QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT | Jun 17, 2004 | Substantially Equivalent |