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510(k) K950883

POLYDOROS SX 65 AND 80 by Siemens Medical Solutions USA, Inc. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1995
Date Received
February 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
Review Panel
RA
Submission Type

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  • K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X- (July 6, 1995)
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  • K950041 — SII 360 APR (March 21, 1995)
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  • K945453 — UD 150L-R II (March 21, 1995)