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510(k) K904623

RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 by Atomic Products Corp. — Product Code IXQ

K904623 is an FDA 510(k) premarket notification submitted by Atomic Products Corp. for the device "RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235". The FDA issued a decision of Substantially Equivalent on November 6, 1990. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Atomic Products Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1990
Date Received
October 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Stationary Top
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Atomic Products Corp.

  • K915541 — SPECT TABLE, MODEL #056-760 (January 17, 1992)
  • K913055 — THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 (September 6, 1991)
  • K904187 — ECONOMY C-ARM TABLE, MODEL # 056-005 (November 29, 1990)
  • K900851 — DIGITAL IMAGE ENHANCEMENT SYSTEM (May 11, 1990)
  • K895799 — RECTILINEAR SCANNER MODEL #187-270 (February 1, 1990)
  • K884312 — ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 (February 16, 1989)
  • K871868 — VENTI-SCAN II (April 11, 1988)
  • K874332 — MRI STRETCHER (January 5, 1988)
  • K790835 — DYNAJECT (June 22, 1979)

Other clearances for product code IXQ

  • K973842 — CARBON FIBER CONFORMAL COUCH TOP (December 5, 1997)
  • K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (July 24, 1996)
  • K954225 — MED-TEC HAND GRIP (November 14, 1995)
  • K946262 — EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES (February 15, 1995)
  • K942916 — OCTOPAQUE UNIVERSAL (September 8, 1994)
  • K942190 — ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE (August 17, 1994)
  • K913425 — DIAL-A-RAD PORTA RAD TABLE (November 24, 1992)
  • K923775 — R-MADE HEAD/ARM SUPPORT (October 20, 1992)
  • K920729 — BUCKY TABLE BK-12 (April 27, 1992)
  • K914351 — CLINITRON C-10 (February 14, 1992)

FDA data resources