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510(k) K843716

NUCLEAR 700 MEDICINE MECHANICAL POSIT- by Technicare Corp. — Product Code IYX

K843716 is an FDA 510(k) premarket notification submitted by Technicare Corp. for the device "NUCLEAR 700 MEDICINE MECHANICAL POSIT-". The FDA issued a decision of Substantially Equivalent on December 17, 1984. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Technicare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1984
Date Received
September 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

Other clearances by Technicare Corp.

  • K854340 — TECHNICARE 720 HPS CT SCANNER (November 15, 1985)
  • K852089 — SATURN NUCLEAR MEDICINE COMPUTER SYSTEM (July 18, 1985)
  • K844293 — AUTO DII MULTI FREQUENCY (February 13, 1985)
  • K844247 — ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS (January 23, 1985)
  • K842777 — AUTOFOCUS DUAL ELEMENT PROBE (November 29, 1984)
  • K841817 — TECHNICARE 248 SL & 260SL (August 17, 1984)
  • K840860 — CENTAURI CT SCANNER (May 22, 1984)
  • K840540 — TECHNICARE MODEL 330 (May 9, 1984)
  • K834486 — TECHNICARE 280 (April 13, 1984)
  • K840390 — TECHNICARE MODEL 1047 (February 21, 1984)

Other clearances for product code IYX

  • K230221 — QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiot (August 28, 2023)
  • K212587 — 3D-RD-S (February 22, 2023)
  • K163687 — OLINDA EXM (July 19, 2017)
  • K160933 — Discovery NM 750b Bopsy (November 18, 2016)
  • K162052 — Sentinella 102, Sentinella 102 Horus (August 18, 2016)
  • K143156 — Sentinella 102; Sentinella 102 Horus (November 18, 2014)
  • K123408 — ERGO IMAGING SYSTEM (January 15, 2013)
  • K111791 — LUMAGEM MOLECULAR BREAST IMAGING SYSTEM (September 23, 2011)
  • K110384 — DILON 6800 ACELLA (ACELLA) (May 3, 2011)
  • K110601 — SENTINELLA 102 (March 18, 2011)

FDA data resources