Teknar Proscan Accessory Probe

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K880659 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Vc III

  Class I

  FDA 510(k) K823011 Active Cleared 8 Nov 1982

• Teknar Proscan(Tm)

  Class II

  FDA 510(k) K864807 Active Cleared 10 Jul 1987

• Pro-Cut Biopsy Needle

  Class II

  FDA 510(k) K891777 Active Cleared 4 May 1989

• Ophthasonic a-Scan

  Class II

  FDA 510(k) K860757 Active Cleared 18 Dec 1986

• Ophthasonic a-Scan/ B-Scan

  Class II

  FDA 510(k) K871536 Active Cleared 26 Aug 1987

• Axisonic II

  Class II

  FDA 510(k) K810697 Active Cleared 13 Jul 1981

See all devices from Teknar, Inc. →

• What types of ultrasound systems is the Teknar Proscan Accessory Probe designed to work with, and how does it improve imaging?

  The Teknar Proscan Accessory Probe is designed as a Class II ultrasound accessory to enhance imaging on existing ultrasound systems. It provides supplementary scanning views or improved resolution for specific anatomical assessments in radiology, acting as an additional scanning element to expand diagnostic capabilities.

• Is the Teknar Proscan Accessory Probe meant for single-use or reusable applications, and how should it be handled?

  The probe is intended for either single-use or reusable applications, depending on facility protocols. If sterile, it must be handled according to infection control guidelines to ensure patient safety. Always follow the manufacturer’s instructions for preparation and use.

• How is the Teknar Proscan Accessory Probe supplied, and does sterility vary by order?

  The probe is supplied either sterile or non-sterile, as specified by the manufacturer’s instructions. Sterility is not a fixed characteristic of the device itself but depends on the configuration ordered, so verify with Teknar or your supplier to confirm the intended sterility status.

• What regulatory pathway was followed for FDA clearance, and what does the product code IYO indicate?

  The Teknar Proscan Accessory Probe received FDA clearance through a traditional 510(k) review process (K880659) with a decision of substantial equivalence (SESE). The product code IYO categorizes it under radiology accessories, specifically ultrasound-related devices, as determined by the FDA’s classification system.