ISITE PACS
FDA 510(k) clearance K042292 · decided 2004-09-08
Clearance details
- K-number
- K042292
- Device name
- ISITE PACS
- Applicant
- Stentor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-24
- Decision date
- 2004-09-08
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Brisbane, CA, US
- Third-party review
- Yes
- Expedited review
- No
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