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510(k) K090296

ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 by Biodex Medical Systems, Inc. — Product Code KPT

K090296 is an FDA 510(k) premarket notification submitted by Biodex Medical Systems, Inc. for the device "ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336". The FDA issued a decision of Substantially Equivalent on February 19, 2009. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360. Biodex Medical Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2009
Date Received
February 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Calibrator, Dose, Radionuclide
Device Class
Class II
Regulation Number
892.1360
Review Panel
RA
Submission Type

Other clearances by Biodex Medical Systems, Inc.

  • K063666 — SHARPS CONTAINER, MODEL 039-413 (January 25, 2007)
  • K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP (November 16, 1995)
  • K950981 — ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 (April 3, 1995)
  • K942694 — STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 (March 10, 1995)
  • K940301 — COMPEX 2 (December 28, 1994)
  • K935520 — UPPER BODY CYCLES (110 VOLT)/(220 VOLT) (September 16, 1994)
  • K935216 — SEMI-RECUMBENT CYCLES (September 16, 1994)
  • K935061 — LOWER BODY CYCLES (September 16, 1994)

Other clearances for product code KPT

  • K192199 — CRC PC Smart Chamber K1 (September 12, 2019)
  • K162394 — CRC-77tHR (March 8, 2017)
  • K142325 — Veenstra Instruments VDC-506 Dose Calibrator (September 18, 2014)
  • K141413 — CRC PC WITH SMART CHAMBER (June 27, 2014)
  • K101452 — CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55 (August 9, 2010)
  • K071396 — CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS (June 28, 2007)
  • K042746 — PET-DOSE (November 22, 2004)
  • K030066 — CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 (August 29, 2003)
  • K011493 — MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRA (October 1, 2002)
  • K020150 — CRC-15BT (August 2, 2002)

FDA data resources