STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER

System, Applicator, Radionuclide, Remote-controlled

STANDARD IMAGING, INC.

The following data is part of a premarket notification filed by Standard Imaging, Inc. with the FDA for Standard Imaging Hdr 1000 Plus Ion Chamber; Standard Imaging Ivb 1000 Ion Chamber.

Pre-market Notification Details

• Device ID: K001825
• 510k Number: K001825
• Device Name: STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER
• Classification: System, Applicator, Radionuclide, Remote-controlled
• Applicant: STANDARD IMAGING, INC. 7601 MURPHY DR. Middleton, WI 53562 -2766
• Contact: Raymond Riddle
• Correspondent: Raymond Riddle; STANDARD IMAGING, INC. 7601 MURPHY DR. Middleton, WI 53562 -2766
• Product Code: JAQ
• CFR Regulation Number: 892.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-06-16
• Decision Date: 2000-08-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00866562000250	K001825	000