DRAD-3000E, RADREX-I— 510(k) K073165
Substantially EquivalentToshiba America Medical Systems, In.C
FDA 510(k) clearance K073165 for DRAD-3000E, RADREX-I, Substantially Equivalent on 2007-11-16. Applicant: Toshiba America Medical Systems, In.C. Device class: 2.
Clearance details
- Applicant
- Toshiba America Medical Systems, In.C
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Recent devices under product code MQB
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