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510(k) K950040

SII 525 APR by Scott Imaging Intl., Inc. — Product Code IZO

K950040 is an FDA 510(k) premarket notification submitted by Scott Imaging Intl., Inc. for the device "SII 525 APR". The FDA issued a decision of Substantially Equivalent on March 21, 1995. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Scott Imaging Intl., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
January 5, 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

Other clearances by Scott Imaging Intl., Inc.

  • K946260 — NTBS-1417, 1436, TBS-1417 (March 31, 1995)
  • K950041 — SII 360 APR (March 21, 1995)
  • K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (February 15, 1995)
  • K946262 — EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES (February 15, 1995)
  • K945709 — SII 525 MS (December 14, 1994)
  • K945708 — SII 360 MS (December 14, 1994)

Other clearances for product code IZO

  • K954666 — MPH50, MPH65, AND MPH80 (November 24, 1995)
  • K953582 — HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR (September 26, 1995)
  • K953831 — N 800 HF (September 8, 1995)
  • K952822 — SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G (July 12, 1995)
  • K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X- (July 6, 1995)
  • K950883 — POLYDOROS SX 65 AND 80 (April 3, 1995)
  • K950694 — COMPACT-X (March 31, 1995)
  • K950291 — DIGITAL 625HF (March 23, 1995)
  • K950041 — SII 360 APR (March 21, 1995)
  • K945453 — UD 150L-R II (March 21, 1995)

FDA data resources