VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER— 510(k) K972686
Substantially EquivalentSmv America
FDA 510(k) clearance K972686 for VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER, Substantially Equivalent on 1997-10-14. Applicant: Smv America. Device class: 2.
Clearance details
- Applicant
- Smv America
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Twinsburg, OH, US
Recent devices under product code KPS
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- K001681 — POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
- K991565 — TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S
Data sourced from openFDA. This site is unofficial and independent of the FDA.