FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL
K Number: K042844
·
Decision Nov 3, 2004
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
54
Review Days
19
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Basic Information
- Device Name
- GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL
- K Number
- K042844
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Medical Systems, Inc.
- Date Received
- October 15, 2004
- Decision Date
- November 3, 2004
- 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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|---|---|---|---|
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| K042053 | INNOVA 4100, INNOVA 3100 | Aug 26, 2004 | Substantially Equivalent |
| K040125 | SENOGRAPHIC STEREO | Apr 19, 2004 | Substantially Equivalent |
| K033244 | DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION | Oct 16, 2003 | Substantially Equivalent |
| K031209 | GE 1.5T 8 CHANNEL TORSO COIL | May 23, 2003 | Substantially Equivalent |
| K023943 | CT COLONOGRAPHY | May 6, 2003 | Substantially Equivalent |
| K030934 | GE LOGIQ 9 MODEL 2375600 | Apr 17, 2003 | Substantially Equivalent |
| K030953 | GE 3.0T GENERAL PURPOSE FLEX COIL | Apr 10, 2003 | Substantially Equivalent |
| K030495 | 3.0T TORSO PHASED ARRAY COIL | Mar 5, 2003 | Substantially Equivalent |