Optidos

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K010705 ↗

FDA Product Code

KXK

Device Class

Class II

Regulation

21 CFR Part 892.5730

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Unidos Universal Dosimeter Model 10002-With Tnc Connector, 10005-With Bnt Connector

  Class II

  FDA 510(k) K951764 Active Cleared 7 Oct 1995

• Ptw Dosimetry Diode, T60008

  Class II

  FDA 510(k) K010916 Active Cleared 20 Jun 2001

• Multidos, QC6PLUS

  Class II

  FDA 510(k) K972211 Active Cleared 10 Sep 1997

• 0.6cc Ionization Chamber - Waterproof 0.6cc Ionization Chamber

  Class II

  FDA 510(k) K961208 Active Cleared 17 Jun 1996

• Ptw-MP3 & Ptw-MP3S Automatic Water Phantom

  Class II

  FDA 510(k) K954165 Active Cleared 5 Dec 1995

• 0.015cc Pinpoint Ionization Chamber, 0.005 Cc Pinpoint Ionization Chamber

  Class II

  FDA 510(k) K972212 Active Cleared 10 Sep 1997

See all devices from Ptw-New York Corp. →

• What is the Optidos used for in medical procedures?

  The Optidos is designed specifically for brachytherapy, a form of internal radiation therapy. It delivers targeted radioactive emissions directly to tissue, allowing precise treatment of localized areas during radiology procedures. This is particularly useful in oncology for treating cancers where external radiation may not be as effective or safe.

• Is the Optidos device intended for single-use or reusable applications?

  The Optidos is supplied for single-use applications only. This design ensures patient safety and sterility, as single-use devices are not intended to be reused or reprocessed. Reuse could compromise the integrity of the radioactive source and introduce risks to both patients and clinicians.

• What regulatory pathway does the Optidos follow, and who oversees its clearance?

  The Optidos is classified as a Class II medical device under FDA regulation 892.5730 and follows the 510(k) clearance process. It was reviewed by the FDA’s Radiology Advisory Committee (RA) and received clearance under the traditional pathway with the decision code SESE (Substantially Equivalent). The clearance number assigned is K010705.

• Are there specific storage conditions or sterility guarantees mentioned for the Optidos?

  The available data does not specify storage conditions or sterility guarantees for the Optidos. Clinicians should follow standard radiation safety protocols for handling radioactive sources and consult manufacturer guidelines for proper storage and handling to ensure safety and efficacy.

• What types of radiology procedures can the Optidos be used in?

  The Optidos is intended for use in brachytherapy procedures within radiology, where precise internal radiation delivery is required. This includes treatments for cancers such as prostate, cervical, or breast cancer, where localized radiation is administered directly to the tumor site. Its use is restricted to controlled clinical settings where trained professionals can manage radioactive materials safely.