Atlas FDA

EASY MOVING PLUS, SM-XXHF-YY

FDA 510(k) clearance K090322 · decided 2009-03-17

Clearance details

K-number
K090322
Device name
EASY MOVING PLUS, SM-XXHF-YY
Applicant
Sedecal., Sa.
Decision
Substantially Equivalent
Date received
2009-02-09
Decision date
2009-03-17
Days to decision
36 days
Clearance type
Special
Product code
IZL
Device class
2
Regulation number
892.1720
Medical specialty
Radiology
Advisory committee
Radiology
Location
Deerfield, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Model Number 40KWMOBILE3.899, Mobile X-ray system recall (Z-0253-2026)SEDECAL SA2025-10-23
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system recall (Z-0254-2026)SEDECAL SA2025-10-23
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system recall (Z-0255-2026)SEDECAL SA2025-10-23
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system recall (Z-0256-2026)SEDECAL SA2025-10-23
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system recall (Z-0257-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system recall (Z-0258-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system recall (Z-0259-2026)SEDECAL SA2025-10-23
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system recall (Z-0260-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system recall (Z-0261-2026)SEDECAL SA2025-10-23
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system recall (Z-0262-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system recall (Z-0263-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system recall (Z-0264-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system recall (Z-0265-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system recall (Z-0266-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system recall (Z-0267-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system recall (Z-0268-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system recall (Z-0269-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system recall (Z-0270-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system recall (Z-0271-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system recall (Z-0272-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system recall (Z-0273-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system recall (Z-0274-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system recall (Z-0275-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system recall (Z-0277-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system recall (Z-0278-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system recall (Z-0279-2026)SEDECAL SA2025-10-23
Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system recall (Z-0280-2026)SEDECAL SA2025-10-23
SED URS LP, Mobile X-ray system recall (Z-0282-2026)SEDECAL SA2025-10-23
SHIMADZU RF.004, Mobile X-ray system recall (Z-0283-2026)SEDECAL SA2025-10-23
SM_40HF_BDC, Mobile X-ray system recall (Z-0286-2026)SEDECAL SA2025-10-23
SM_40HF_BDC3, Mobile X-ray system recall (Z-0287-2026)SEDECAL SA2025-10-23