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510(k) K844549

HEAD-SPINE STABILIZER HSS-1 by Imaging Accessories, Inc. — Product Code IWY

K844549 is an FDA 510(k) premarket notification submitted by Imaging Accessories, Inc. for the device "HEAD-SPINE STABILIZER HSS-1". The FDA issued a decision of Substantially Equivalent on March 1, 1985. The device falls under product code IWY (Holder, Head, Radiographic), a Class I device regulated under 21 CFR 892.1920. Imaging Accessories, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1985
Date Received
November 21, 1984
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 Imaging Accessories, Inc.

  • K844926 — HEAD-SPINE STABILIZER HSS-1 (April 16, 1985)

Other clearances for product code IWY

  • K925705 — ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM (December 28, 1992)
  • 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)
  • 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