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510(k) K952265

MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR by Control-X, Inc. — Product Code IZO

K952265 is an FDA 510(k) premarket notification submitted by Control-X, Inc. for the device "MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR". The FDA issued a decision of Substantially Equivalent on July 6, 1995. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Control-X, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1995
Date Received
May 15, 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 Control-X, Inc.

  • K920347 — TOP-X 650HF RADIOGRAPHIC X-RAY (May 17, 1993)
  • K924445 — BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (February 19, 1993)
  • K920351 — PCX 650HF RADIOGRAPHIC X-RAY (February 12, 1993)
  • K920349 — PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR (February 12, 1993)
  • K924443 — RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE (February 5, 1993)
  • K924444 — B-4 FOUR-WAY RADIOGRAPHIC TABLE (February 5, 1993)
  • K913577 — MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR (November 5, 1991)
  • K913578 — MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR (November 1, 1991)

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)
  • K950883 — POLYDOROS SX 65 AND 80 (April 3, 1995)
  • K950694 — COMPACT-X (March 31, 1995)
  • K950291 — DIGITAL 625HF (March 23, 1995)
  • K950040 — SII 525 APR (March 21, 1995)
  • K950041 — SII 360 APR (March 21, 1995)
  • K945453 — UD 150L-R II (March 21, 1995)

FDA data resources