FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOLUCENT MAMMOGRAPHY CUSHION
K Number: K003795
·
Decision Feb 14, 2001
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
6
Review Days
68
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Basic Information
- Device Name
- BIOLUCENT MAMMOGRAPHY CUSHION
- K Number
- K003795
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biolucent, Inc.
- Date Received
- December 8, 2000
- Decision Date
- February 14, 2001
- Product Code
- IZH
- 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 |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
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Other Clearances by Biolucent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070659 | BIOLUCENT APPLICATOR KIT | Apr 4, 2007 | Unknown |
| K062830 | BIOLUCENT APPLICATOR KIT | Oct 20, 2006 | Substantially Equivalent |
| K062141 | MAMMOPAD RADIOLUCENT CUSHION | Sep 13, 2006 | Substantially Equivalent |
| K061241 | BIOLUCENT APPLICATOR, MODEL RTA-XX | Jul 28, 2006 | Substantially Equivalent |
| K053595 | CURAY CUSTOM SEED ARRAY | Feb 28, 2006 | Substantially Equivalent |