Home / 510(k) Clearances / K860193

510(k) K860193

PORTALCAST by Diacor, Inc. — Product Code IXI

K860193 is an FDA 510(k) premarket notification submitted by Diacor, Inc. for the device "PORTALCAST". The FDA issued a decision of Substantially Equivalent on January 30, 1986. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. Diacor, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1986
Date Received
January 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Beam-Shaping, Radiation Therapy
Device Class
Class II
Regulation Number
892.5710
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)
  • K954414 — CENTRALITE BACKPOINTER (October 23, 1995)
  • 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)

Other clearances for product code IXI

  • K253025 — Ricoh 3D for Healthcare Bolus (April 6, 2026)
  • K222639 — VHA Radiotherapy Bolus (November 4, 2022)
  • K214093 — VSP Bolus (March 30, 2022)
  • K132236 — .DECIMAL PROTON APERTURE (October 16, 2013)
  • K131150 — CURA COMPENSATOR (July 30, 2013)
  • K123893 — CURA COLLIMATOR (March 4, 2013)
  • K123015 — .DECIMAL PHOTON BLOCK (November 21, 2012)
  • K111676 — APEX (September 30, 2011)
  • K111759 — .DECIMAL ELECTRON APERTURE (September 9, 2011)
  • K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (July 29, 2009)

FDA data resources