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510(k) K871868

VENTI-SCAN II by Atomic Products Corp. — Product Code IYT

K871868 is an FDA 510(k) premarket notification submitted by Atomic Products Corp. for the device "VENTI-SCAN II". The FDA issued a decision of Substantially Equivalent on April 11, 1988. The device falls under product code IYT (System, Rebreathing, Radionuclide), a Class II device regulated under 21 CFR 892.1390. Atomic Products Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1988
Date Received
May 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Rebreathing, Radionuclide
Device Class
Class II
Regulation Number
892.1390
Review Panel
RA
Submission Type

Other clearances by Atomic Products Corp.

  • K915541 — SPECT TABLE, MODEL #056-760 (January 17, 1992)
  • K913055 — THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 (September 6, 1991)
  • K904187 — ECONOMY C-ARM TABLE, MODEL # 056-005 (November 29, 1990)
  • K904623 — RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 (November 6, 1990)
  • K900851 — DIGITAL IMAGE ENHANCEMENT SYSTEM (May 11, 1990)
  • K895799 — RECTILINEAR SCANNER MODEL #187-270 (February 1, 1990)
  • K884312 — ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 (February 16, 1989)
  • K874332 — MRI STRETCHER (January 5, 1988)
  • K790835 — DYNAJECT (June 22, 1979)

Other clearances for product code IYT

  • K253942 — Pulmonex II Xenon System (132-503) (July 7, 2026)
  • K200916 — Patient Administration Set (September 1, 2020)
  • K953513 — XENON CIRCUIT (November 3, 1995)
  • K952223 — XENON GAS BREATHING CIRCUIT (August 11, 1995)
  • K914747 — XENON CIRCUIT (February 27, 1992)
  • K913416 — TETLEY PATIENT ADMINISTRATION SET (October 28, 1991)
  • K912626 — BOLUS XENON CIRCUIT (August 2, 1991)
  • K904684 — AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION (January 14, 1991)
  • K903805 — AMICI XENON ADMINISTRATION SET (January 14, 1991)
  • K903694 — AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE (October 3, 1990)

FDA data resources