ISORAY MEDICAL, INC.

United States(FDA 510(k) applicant) Last updated 30 May 2026

Devices: 27
Registries: GUDIDFDA 510(k)
FDA recalls: 0

Catalogue27

Cesitrex™ 8160 Ref 8160

Class II FDA UDI Active
GliaSite® Access Tray 9005 Ref 9005

Class II FDA UDI Active
Blu Blade BB-1 Ref BB-1

Class I FDA UDI
Strand Cutter BB-1 Ref BB-1

Class I FDA UDI
GliaSite® Catheter Tray 1030 Ref 1030

Class II FDA UDI Active
Iotrex® 8150 Ref 8150

Class II FDA UDI Active
Proxcelan™ Cs-131 Preloaded Braided Strands PL-5 Ref PL-5

Class II FDA UDI
Proxcelan™ Cs-131 Brachytherapy Seeds Ref CS-1

Class II FDA UDI
Proxcelan™ Cs-131 Preloaded S-Cartridges PL-4 Ref PL-4

Class II FDA UDI
Proxcelan™ Cs-131 Preloaded Braided Strands PL-5M Ref PL-5M

Class II FDA UDI
GliaSite® Catheter Tray 1040 Ref 1040

Class II FDA UDI Active
Blu Build Real Time Loader Device BBL-1 Ref BBL-1

Class I FDA UDI
PL-8 Cs-131 Brachytherapy Seeds Preloaded Strands in 18G Needles with MRI Marker Ref PL-8

Class II FDA UDI
PL-7 Cs-131 Brachytherapy Seeds in Preloaded Strands with MRI Markers Ref PL-7

Class II FDA UDI
Proxcelan™ Cs-131 Strands PL-1 Ref PL-1

Class II FDA UDI
Blu Build Sleeve Carrier BBS-1 Ref BBS-1

Class I FDA UDI
Blu Build Spacer Cartridge BBC-1 Ref BBC-1

Class I FDA UDI
Proxcelan™ Cs-131 Preloaded 18G Needles PL-3 Ref PL-3

Class II FDA UDI
Proxcelan™ Cs-131 Preloaded Mick® Cartridges - Non Sterile PL-4NS Ref PL-4NS

Class II FDA UDI
Proxcelan™ Cs-131 Brachytherapy Seeds CS-1NS Ref CS-1NS

Class II FDA UDI
GliaSite® Catheter Tray 1020 Ref 1020

Class II FDA UDI Active
Proxcelan™ Cs-131 Preloaded Strands in 18G Needles PL-2 Ref PL-2

Class II FDA UDI
Proxcelan Cs-131PRELOADED Strands, Model Pl-1, Proxcelan Cs-131 Preloaded Strands In 18 Guage Needles, Model Pl-2 Ref K092458

Class II FDA 510(k) Active
GammaTile Ref K180515

Class II FDA 510(k) Active
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles Ref K202267

Class II FDA 510(k) Active
Gliasite Rts Ref K111931

Class II FDA 510(k) Active
Proxcelan Cs-131 Preloaded Braided Strands, Model: Pl-5 Ref K092136

Class II FDA 510(k) Active

What ISORAY MEDICAL, INC. makes

The company manufactures manual applicators and components for brain brachytherapy, including preloaded radioactive iodine-131 (Cs-131) strands, braided strands, MRI-compatible markers, and catheter trays designed for intracranial use. Products include single-use applicators like the Cesitrex™ system, preloaded needles for interstitial implantation, and specialized trays for catheter placement. The portfolio also covers MRI-visible markers for post-procedure localization and preloaded braided strands for flexible delivery.

These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearance and the Unique Device Identifier (UDI) system. The company’s products are listed in the FDA’s regulatory databases, ensuring compliance with US medical device standards. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States(Country (from FDA 510(k) applicant address))
Website: isoray.com
Email: [email protected]
Phone: 509-375-5329
DUNS number: 113577485

Catalogue27

Cesitrex™ 8160 Ref 8160

GliaSite® Access Tray 9005 Ref 9005

Blu Blade BB-1 Ref BB-1

Strand Cutter BB-1 Ref BB-1

GliaSite® Catheter Tray 1030 Ref 1030

Iotrex® 8150 Ref 8150

Proxcelan™ Cs-131 Preloaded Braided Strands PL-5 Ref PL-5

Proxcelan™ Cs-131 Brachytherapy Seeds Ref CS-1

Proxcelan™ Cs-131 Preloaded S-Cartridges PL-4 Ref PL-4

Proxcelan™ Cs-131 Preloaded Braided Strands PL-5M Ref PL-5M

GliaSite® Catheter Tray 1040 Ref 1040

Blu Build Real Time Loader Device BBL-1 Ref BBL-1

PL-8 Cs-131 Brachytherapy Seeds Preloaded Strands in 18G Needles with MRI Marker Ref PL-8

PL-7 Cs-131 Brachytherapy Seeds in Preloaded Strands with MRI Markers Ref PL-7

Proxcelan™ Cs-131 Strands PL-1 Ref PL-1

Blu Build Sleeve Carrier BBS-1 Ref BBS-1

Blu Build Spacer Cartridge BBC-1 Ref BBC-1

Proxcelan™ Cs-131 Preloaded 18G Needles PL-3 Ref PL-3

Proxcelan™ Cs-131 Preloaded Mick® Cartridges - Non Sterile PL-4NS Ref PL-4NS

Proxcelan™ Cs-131 Brachytherapy Seeds CS-1NS Ref CS-1NS

GliaSite® Catheter Tray 1020 Ref 1020

Proxcelan™ Cs-131 Preloaded Strands in 18G Needles PL-2 Ref PL-2

Proxcelan Cs-131PRELOADED Strands, Model Pl-1, Proxcelan Cs-131 Preloaded Strands In 18 Guage Needles, Model Pl-2 Ref K092458

GammaTile Ref K180515

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles Ref K202267

Gliasite Rts Ref K111931

Proxcelan Cs-131 Preloaded Braided Strands, Model: Pl-5 Ref K092136

What ISORAY MEDICAL, INC. makes

Information