FLEXITRON

System, Applicator, Radionuclide, Remote-controlled

ISODOSE CONTROL B.V.

The following data is part of a premarket notification filed by Isodose Control B.v. with the FDA for Flexitron.

Pre-market Notification Details

• Device ID: K070574
• 510k Number: K070574
• Device Name: FLEXITRON
• Classification: System, Applicator, Radionuclide, Remote-controlled
• Applicant: ISODOSE CONTROL B.V. LANDJUWEEL 11 Veenendaal, NL 3905 Pe
• Contact: Hub Van De Bergh
• Correspondent: Hub Van De Bergh; ISODOSE CONTROL B.V. LANDJUWEEL 11 Veenendaal, NL 3905 Pe
• Product Code: JAQ
• CFR Regulation Number: 892.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-28
• Decision Date: 2007-04-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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08717213011281	K070574	000
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