MRINNERVU Disposable Endorectal Colon Coil, #PCC-15
by Medrad, Inc.
510(k) K930544
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930544 | Date29 Sep 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LNH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The MRINNERVU Disposable Endorectal Colon Coil (#PCC-15) is a single-use, disposable coil designed for use in magnetic resonance imaging (MRI) systems. It is classified as a System, Nuclear Magnetic Resonance Imaging device and functions as an endorectal coil, which enhances image resolution and contrast for MRI examinations of the pelvic region, particularly the prostate, rectum, and surrounding structures. This coil is inserted into the rectum to improve signal-to-noise ratio and spatial resolution during MRI scans.
The coil is intended for single-use and is supplied sterile for clinical use in MRI-compatible settings. It is classified as a Class II device under FDA regulations (Regulation 892.1000) and was granted FDA 510(k) clearance (K930544) in 1993 under the Traditional clearance pathway. The device is intended for use in radiology departments and requires proper handling, storage, and disposal in accordance with MRI safety protocols. No third-party review was conducted for this submission.