2D PERFUSION
FDA 510(k) clearance K132147 · decided 2013-12-16
Clearance details
- K-number
- K132147
- Device name
- 2D PERFUSION
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-11
- Decision date
- 2013-12-16
- Days to decision
- 158 days
- Clearance type
- Abbreviated
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Best Noord-Brabant, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 recall (Z-1417-2023) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2023-04-20 |