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.

IsoLoc · Prostate Immobilizer Rectal Balloon → Radiology

Name: IsoLoc
Brand: IsoLoc

1manufacturer

3catalogue numbers in this listing

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 IsoLoc
Listed by	Radiadyne, L.L.C.
FDA product code	PCT
Device type	Prostate Immobilizer Rectal Balloon
Device class	Class 2
Regulation	21 CFR 892.5720
510(k)	DEN130036
Record published	2018-01-31
Record revised	2024-11-05 (version 6)

Specifications

Specifications
MRI safety	MR Conditional
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature -30 to 50 °C
Packaging	Shipper box of 5, shelf package of 20, shelf box of 20
Distribution end date	2018-01-31

Catalogue Numbers

Catalogue numbers for IsoLoc
Catalogue number	Size	Status
ISO-100		In distribution
ISO-60		In distribution
ISO-60		Withdrawn

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
Qlrad	Qlrad	3
Bionix Radiation Therapy	Bionix Radiation Therapy, LLC	2

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of IsoLoc
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
AngioDynamics, Inc.	UDI-DI	2025-02-04	Class II	Process control	Product is mislabeled with the incorrect fill volume.	1,800 units
AngioDynamics, Inc.	UDI-DI	2024-05-21	Class II	Under Investigation by firm	A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).	1,500 units (75 kits with 20 units per kit)

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.

IsoLoc