PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
FDA 510(k) clearance K034054 · decided 2004-02-20
Clearance details
- K-number
- K034054
- Device name
- PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
- Applicant
- Med-Tec,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-30
- Decision date
- 2004-02-20
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- JAI
- Device class
- 2
- Regulation number
- 892.5770
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Orange City, IA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.