FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
breastscape v1.0
K Number: K211431
·
Decision Aug 2, 2021
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
11
Review Days
87
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Basic Information
- Device Name
- breastscape v1.0
- K Number
- K211431
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olea Medical
- Date Received
- May 7, 2021
- Decision Date
- August 2, 2021
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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Other Clearances by Olea Medical
| K Number | Device Name | ||
|---|---|---|---|
| K223091 | CT Perfusion V1.0 | Jun 9, 2023 | Substantially Equivalent |
| K223532 | Olea S.I.A. Neurovascular V1.0 | Jun 6, 2023 | Substantially Equivalent |
| K230552 | MR DWI/FLAIR Measurement V1.0 | Apr 26, 2023 | Substantially Equivalent |
| K223502 | MR Diffusion Perfusion Mismatch V1.0 | Jan 13, 2023 | Substantially Equivalent |
| K152602 | Olea Sphere V3.0 | Mar 3, 2016 | Substantially Equivalent |
| K132095 | OLEA SPHERE | Dec 26, 2013 | Substantially Equivalent |
| K120196 | OLEA SPHERE | Apr 19, 2012 | Substantially Equivalent |
| K111161 | PERFSCAPE V2.0 | Nov 4, 2011 | Substantially Equivalent |
| K091444 | PERFSCAPE | Jul 20, 2009 | Substantially Equivalent |
| K083491 | NEUROSCAPE | Feb 19, 2009 | Substantially Equivalent |