FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCESS BREAST COIL
K Number: K052045
·
Decision Aug 24, 2005
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
9
Review Days
27
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Basic Information
- Device Name
- ACCESS BREAST COIL
- K Number
- K052045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Confirma, Inc.
- Date Received
- July 28, 2005
- Decision Date
- August 24, 2005
- 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 Confirma, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K092954 | CADSTREAM VERSION 5 | Nov 6, 2009 | Substantially Equivalent |
| K081556 | CADSTREAM, VERSION 5.0 | Feb 2, 2009 | Substantially Equivalent |
| K071534 | CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS | Jul 9, 2007 | Substantially Equivalent |
| K060547 | ACCESS BREAST COIL 4/SMS | Mar 29, 2006 | Substantially Equivalent |
| K043216 | CADSTREAM VERSION 4.0 | Jan 6, 2005 | Substantially Equivalent |
| K041020 | CADSTREAM VERSION 3.1 | Jul 7, 2004 | Substantially Equivalent |
| K031779 | CADSTREAM | Aug 6, 2003 | Substantially Equivalent |
| K013574 | ACCENT | Jan 15, 2002 | Substantially Equivalent |