Home / 510(k) Clearances / K922554

510(k) K922554

STANDARD IMAGING HDR 1000 ION CHAMBER by Standard Imaging, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1992
Date Received
May 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

Other clearances by Standard Imaging, Inc.

  • K103193 — DOSEVIEW 3D (December 27, 2010)
  • K082773 — STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 (November 19, 2008)
  • K060532 — HDR 1000 PLUS WELL CHAMBER, MODEL 90008 (April 11, 2006)
  • K042733 — STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM (November 15, 2004)
  • K040688 — STANDARD IMAGING E.IMRT CALCULATOR (May 11, 2004)
  • K013548 — STANDARD IMAGING IVB 1000 WELL CHAMBER (November 9, 2001)
  • K002833 — MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER (September 28, 2000)
  • K001825 — STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBE (August 2, 2000)
  • K940539 — STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM (March 16, 1994)

Other clearances for product code JAQ

  • K251037 — Rectal Applicator (December 19, 2025)
  • K252884 — Guided Aarhus Applicator Set (November 19, 2025)
  • K250299 — CT/ MR Tandem and Ovoid Set (May 9, 2025)
  • K250289 — Intracavitary/Interstitial System (April 25, 2025)
  • K243939 — Titanium Flexible Geometry FSD Applicator Set (GM11013400) (March 3, 2025)
  • K241764 — Mould Probe MR Safe (January 10, 2025)
  • K242961 — Intraluminal Applicator Set (November 26, 2024)
  • K243045 — “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (November 19, 2024)
  • K241853 — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (November 7, 2024)
  • K241965 — Catheter Surface Flap Applicator Set (GM11011830) (October 29, 2024)