XOFT AXXENT CERVICAL APPLICATORS— 510(k) K123442
Substantially EquivalentIcad, Inc.
FDA 510(k) clearance K123442 for XOFT AXXENT CERVICAL APPLICATORS, Substantially Equivalent on 2013-02-27. Applicant: Icad, Inc.. Device class: 2.
Clearance details
- Applicant
- Icad, Inc.
- Product code
- Code JAQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5700
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nashua, NH, US
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