FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K Number: K000002
·
Decision Feb 23, 2000
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
478
Applicant Total
64
Review Days
51
Basic Information
- Device Name
- MAGNA 5000 PHASED ARRAY CTL SPINE COIL
- K Number
- K000002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- USA INSTRUMENTS, INC.
- Date Received
- January 3, 2000
- Decision Date
- February 23, 2000
- Product Code
- MOS
- 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOS), ordered by most recent decision date.
16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
FDA 510(k)
FDA Class 2
·Radiology
InkSpace Imaging Small Body Array
FDA 510(k)
FDA Class 2
·Radiology
XENOVIEW 3.0T Chest Coil
FDA 510(k)
FDA Class 2
·Radiology
dS Wrist coil 8ch 1.5T
FDA 510(k)
FDA Class 2
·Radiology
dS Knee Coil 8ch 1.5T
FDA 510(k)
FDA Class 2
·Radiology
dS FootAnkle Coil 8ch 1.5T
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by USA INSTRUMENTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K052916 | USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY | Nov 9, 2005 | Substantially Equivalent |
| K052584 | 1.5T 12 CHANNEL BODY ARRAY | Oct 7, 2005 | Substantially Equivalent |
| K052621 | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL | 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 |
| K042207 | 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL | Aug 26, 2004 | Substantially Equivalent |
| K042186 | 3.0T 8-CHANNEL CTL SPINE ARRAY | Aug 26, 2004 | Substantially Equivalent |
| K042009 | MARK III PHASED ARRAY SHOULDER COIL | Aug 11, 2004 | Substantially Equivalent |
| K041695 | LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE | Jul 23, 2004 | Substantially Equivalent |