Home / 510(k) Clearances / K922443

510(k) K922443

VERT-X UNIVERSAL VERTICAL BUCKY STAND by Afp Imaging Corp. — Product Code IXY

K922443 is an FDA 510(k) premarket notification submitted by Afp Imaging Corp. for the device "VERT-X UNIVERSAL VERTICAL BUCKY STAND". The FDA issued a decision of Substantially Equivalent on October 26, 1992. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Afp Imaging Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1992
Date Received
May 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Radiographic Cassette, Wall-Mounted
Device Class
Class I
Regulation Number
892.1880
Review Panel
RA
Submission Type

Other clearances by Afp Imaging Corp.

  • K123419 — EVA SELECT DIGITAL DENTAL IMAGING SYSTEM (December 27, 2012)
  • K072357 — NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM (September 18, 2007)
  • K041120 — EV APAN DIGITAL, MODEL K1VSM2000 (August 30, 2004)
  • K030647 — EVA DIGITAL DENTAL X-RAY SYSTEM (March 20, 2003)
  • K014144 — EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 (February 7, 2002)
  • K013176 — MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE (October 16, 2001)
  • K974619 — SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM (February 25, 1998)
  • K950288 — AUTOLASER MULTI FORMAT CAMERA (April 4, 1995)
  • K925885 — AFP 17 X 4 AUTOMATIC FILM PROCESSOR (June 9, 1993)
  • K930761 — IMAGE-X 70 INTRAORAL X-RAY SYSTEM (May 25, 1993)

Other clearances for product code IXY

  • K953402 — UNIVERSIX 190 (August 11, 1995)
  • K953336 — VRS 3 WALL STAND (August 11, 1995)
  • K946114 — SENSORI-MOTOR RATING SCALE (April 28, 1995)
  • K946260 — NTBS-1417, 1436, TBS-1417 (March 31, 1995)
  • K930230 — RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (April 27, 1993)
  • K930249 — BC/WT/PF (April 27, 1993)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)
  • K924445 — BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (February 19, 1993)
  • K915667 — MODEL H170 PEDIATRIC CHEST X-RAY UNIT (January 31, 1992)
  • K895034 — BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C (November 15, 1989)

FDA data resources