SOPHYCAMERA DSX BODYTRAK— 510(k) K911346
Substantially EquivalentSopha Medical Systems, Inc.
FDA 510(k) clearance K911346 for SOPHYCAMERA DSX BODYTRAK, Substantially Equivalent on 1991-04-18. Applicant: Sopha Medical Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Sopha Medical Systems, Inc.
- Product code
- Code IYX
- Device class
- Class 1
- Regulation
- 21 CFR 892.1100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
Recent devices under product code IYX
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view allRecalls naming K911346
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K911346.
Data sourced from openFDA. This site is unofficial and independent of the FDA.