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510(k) K954414

CENTRALITE BACKPOINTER by Diacor, Inc. — Product Code IWE

K954414 is an FDA 510(k) premarket notification submitted by Diacor, Inc. for the device "CENTRALITE BACKPOINTER". The FDA issued a decision of Substantially Equivalent on October 23, 1995. The device falls under product code IWE (Monitor, Patient Position, Light-Beam), a Class I device regulated under 21 CFR 892.5780. Diacor, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1995
Date Received
September 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Patient Position, Light-Beam
Device Class
Class I
Regulation Number
892.5780
Review Panel
RA
Submission Type

Other clearances by Diacor, Inc.

  • K121929 — ZEPHYR 'X-SERIES PATIENT TRANSFER SLED (January 17, 2013)
  • K050888 — INTEGRA IMMOBILIZATION SYSTEM (May 23, 2005)
  • K953046 — PERI-PUSHER (September 22, 1995)
  • K950112 — CENTRALITE(R)-DLL SERIES (August 16, 1995)
  • K934566 — RADASSIST (November 3, 1993)
  • K930246 — MAMMORX (July 26, 1993)
  • K893398 — CENTRALITE BACKPOINTER (August 17, 1989)
  • K872489 — CENTRALITE (July 15, 1987)
  • K860193 — PORTALCAST (January 30, 1986)

Other clearances for product code IWE

  • K152303 — CT Sim Laser System (September 11, 2015)
  • K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (November 20, 1997)
  • K955236 — GREEN TEC-2100 (May 24, 1996)
  • K950293 — TEC-2110 GREEN LASER MODEL MT-HNG (August 18, 1995)
  • K950112 — CENTRALITE(R)-DLL SERIES (August 16, 1995)
  • K951601 — MED-TEC STRING RETICLE TRAY (May 11, 1995)
  • K943802 — HP BACK POINTER SYSTEM (December 7, 1994)
  • K943381 — LASER ALIGNMENT TOOL (August 9, 1994)
  • K941169 — TEC 2101 (MODEL MT-HPLGD) (July 18, 1994)
  • K935760 — TEC 2100 (MODEL MT-LPLGD) (January 25, 1994)

FDA data resources