Home / 510(k) Clearances / K943926

510(k) K943926

RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE by Philips Medical Systems (Cleveland), Inc. — Product Code IZZ

K943926 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE". The FDA issued a decision of Substantially Equivalent on November 28, 1994. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. Philips Medical Systems (Cleveland), Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1994
Date Received
August 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Non-Tilting, Powered
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Philips Medical Systems (Cleveland), Inc.

  • K171850 — Philips CT Big Bore (November 9, 2017)
  • K172406 — Ingenuity TF (October 6, 2017)
  • K162838 — Philips iCT CT System (April 7, 2017)
  • K163711 — IQon Spectral CT (April 5, 2017)
  • K170086 — Pinnacle Radiation Therapy Planning System (February 9, 2017)
  • K160743 — Philips Ingenuity CT (August 8, 2016)
  • K153444 — Philips Multislice CT System with Low Dose CT Lung Cancer (April 8, 2016)
  • K130992 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (June 14, 2013)
  • K111336 — EBW NM 2.0 (May 24, 2011)
  • K111024 — JETPACK 2.0 (April 21, 2011)

Other clearances for product code IZZ

  • K971452 — MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE (May 14, 1997)
  • K952701 — MED-TRON SPECT IMAGING TABLE (July 6, 1995)
  • K951315 — CATHETERIZATION TABLE KS-60 (May 11, 1995)
  • K951053 — ANGIOREX CAT-350B (April 6, 1995)
  • K930273 — ALPHA (July 13, 1993)
  • K924444 — B-4 FOUR-WAY RADIOGRAPHIC TABLE (February 5, 1993)
  • K925174 — SHIMADZU RADIOGRAPHIC TABLE BK-100 (November 27, 1992)
  • K921501 — DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 (May 15, 1992)
  • K920732 — CATHERIZATION KS-50 (April 16, 1992)
  • K915413 — CAT-250B (December 19, 1991)

FDA data resources