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510(k) K925705

ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM by Denar Corp. — Product Code IWY

K925705 is an FDA 510(k) premarket notification submitted by Denar Corp. for the device "ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM". The FDA issued a decision of Substantially Equivalent on December 28, 1992. The device falls under product code IWY (Holder, Head, Radiographic), a Class I device regulated under 21 CFR 892.1920. Denar Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1992
Date Received
November 12, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Radiographic
Device Class
Class I
Regulation Number
892.1920
Review Panel
RA
Submission Type

Other clearances by Denar Corp.

  • K924759 — COLLIMATOR LIGHT SOURCE (December 9, 1992)
  • K884845 — STERI-OSS (February 10, 1989)
  • K883373 — STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT (January 13, 1989)
  • K852802 — DENAR DENTAL IMPLANT (September 23, 1985)

Other clearances for product code IWY

  • K884493 — HEAD HOLDING DEVICE/SLEEP APNEA (January 12, 1989)
  • K884847 — MTD HEDREST (January 9, 1989)
  • K864527 — DUOCEPH (January 7, 1987)
  • K850197 — KELLER CEPHALOMETRIC DEVICE (March 22, 1985)
  • K844549 — HEAD-SPINE STABILIZER HSS-1 (March 1, 1985)
  • K843340 — PORTA-STAT (November 27, 1984)
  • K834559 — DELUXE WALL-MOUNTED CEPHALOMETER (February 21, 1984)
  • K802140 — LEKSELL STEREOTACTIC SYSTEM (February 5, 1981)
  • K772313 — X-RAY CO-ORDINATOR (January 30, 1978)

FDA data resources