What is FDA product code PCT?

Intended to be used for the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose is to stabilize the prostate during computed tomography (CT) exam, X-ray, or radiation therapy (RT) treatments. The placement of the balloon requires a physician or a physician-directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.

Radiology › TherapeuticProstate Immobilizer Rectal Balloon

Qlrad

Name: Qlrad
Brand: Qlrad

RectalPro75, switch valve LL with 100 cc Syringe

Registry build 21.09.26

1manufacturer

3catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PCT
Manufacturer	City	Province	Registered as	Device types
Koo (Shanghai) Industries Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	9

Record

Regulatory record for Qlrad
Listed by	Qlrad, Netherlands
FDA product code	PCT
Device type	Prostate Immobilizer Rectal Balloon
Device class	Class 2
Regulation	21 CFR 892.5720
Establishment	Specification developer, Manufacturer, Exporter
510(k)	K180478
Record published	2020-09-28
Record revised	2021-05-26 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Box of 100, box of 50, box of 2
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Qlrad
Catalogue number	Size	Status
105.1014		In distribution
105.1001		In distribution
105.1018		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ImmobiLoc	Radiadyne, L.L.C.	5
Prostate Caddy Rectal Balloon	Myriad Medical LLC	3
IsoLoc	Radiadyne, L.L.C.	3
Bionix Radiation Therapy	Bionix Radiation Therapy, LLC	2

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K180478	2018-11-13

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.