FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1.5T SCANMED PV ARRAY
K Number: K022395
·
Decision Aug 13, 2002
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
12
Review Days
21
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Basic Information
- Device Name
- 1.5T SCANMED PV ARRAY
- K Number
- K022395
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medic, Inc.
- Date Received
- July 23, 2002
- Decision Date
- August 13, 2002
- 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 |
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Other Clearances by Medic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951649 | MODEL #801GE1500 PEDIATRIC ARRAY COIL | Jun 22, 1995 | Substantially Equivalent |
| K942874 | MODEL #300TO3500 SHOULDER COIL | Dec 8, 1994 | Substantially Equivalent |
| K942873 | MODEL #700TO3500 NECK/ABDOMINAL COIL | Dec 2, 1994 | Substantially Equivalent |
| K942875 | MODEL #900TO3500 HEAD/NECK COIL | Dec 2, 1994 | Substantially Equivalent |
| K942355 | MODEL #310T03500 WRIST COIL | Sep 16, 1994 | Substantially Equivalent |
| K940874 | MODEL 900GE1500 HEAD/NECK COIL | Jun 3, 1994 | Substantially Equivalent |
| K933295 | MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA | Mar 17, 1994 | Substantially Equivalent |
| K933296 | MODEL #310GE1500 WRIST COIL | Mar 17, 1994 | Substantially Equivalent |
| K933659 | MODEL #100GE1500 LOWER EXTREM QUAD DETECT ARRAY COIL | Nov 22, 1993 | Substantially Equivalent |
| K933658 | MODEL 300GE1500 SHOULDER COIL | Nov 19, 1993 | Substantially Equivalent |