ACQPLAN 5.0
FDA 510(k) clearance K013644 · decided 2002-09-12
Clearance details
- K-number
- K013644
- Device name
- ACQPLAN 5.0
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-05
- Decision date
- 2002-09-12
- Days to decision
- 311 days
- Clearance type
- Traditional
- Product code
- MUJ
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.