Prostate Probe Surface Coil Catalog BPX-15

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

510(k) Number

K901888 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Mriinnervu Disposable Endorectal Cervic Coil, Catalog No. Bcr-15

  Class II

  FDA 510(k) K952235 Active Cleared 26 Jun 1995

• Medrad Phased Array 1.5T Shoulder Imaging Surface Coil

  Class II

  FDA 510(k) K960901 Active Cleared 29 May 1996

• Benzalkonium-Heparin Coated Guidewires

  Class II

  FDA 510(k) K802473 Active Cleared 12 Nov 1980

• Medrad Counterpoise System

  Class II

  FDA 510(k) K944983 Active Cleared 29 Nov 1994

• Medrad Fluoroscopic Video Enhancement System

  Class II

  FDA 510(k) K884317 Active Cleared 20 Dec 1988

• Mrinnervu Endorectal Prostate Coil

  Class II

  FDA 510(k) K925029 Active Cleared 19 May 1993

See all devices from Medrad, Inc. →

• What is the primary purpose of the Prostate Probe Surface Coil, Catalog #BPX-15, in MRI imaging?

  The Prostate Probe Surface Coil, Catalog #BPX-15, is designed to enhance MRI signal quality specifically for prostate imaging. By improving the signal-to-noise ratio, it provides clearer visualization of the prostate gland, aiding in diagnostic evaluations for prostate-related conditions.

• Is the Prostate Probe Surface Coil, Catalog #BPX-15, intended for single-use or reusable applications?

  The Prostate Probe Surface Coil, Catalog #BPX-15, is explicitly supplied as a single-use device. This means it is not intended for reuse after a single procedure, and proper disposal protocols should be followed after use.

• What type of sterility does the Prostate Probe Surface Coil, Catalog #BPX-15, have, and how should it be handled?

  The Prostate Probe Surface Coil, Catalog #BPX-15, is non-sterile as supplied. Since it is intended for use in radiology settings, it must be handled in accordance with standard MRI safety protocols, including proper cleaning and preparation of the patient and equipment to ensure a sterile field during imaging.

• Which regulatory body has cleared this device, and what was the decision type for its approval?

  The Prostate Probe Surface Coil, Catalog #BPX-15, holds an FDA 510(k) clearance under the Radiology advisory committee. The clearance was granted as substantially equivalent to a predicate device, meaning it was determined to have the same intended use and technological characteristics as an existing approved device.

• Are there any specific storage requirements mentioned for the Prostate Probe Surface Coil, Catalog #BPX-15?

  The provided data does not specify detailed storage requirements for the Prostate Probe Surface Coil, Catalog #BPX-15. However, as a single-use, non-sterile device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until use.