FDA.reportPublic FDA data

BSD-500 Hyperthermia System

Primary DI
00864445000434
Brand
BSD-500 Hyperthermia System
Company
Pyrexar Medical Inc.
Model
BSD-500
Device description
The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malignant tumors by the external or interstitial application of electromagnetic energy and monitors the temperature of target and surrounding tissues by means of independent temperature sensors.
Published
2023-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOCSystem, Rf/Microwave Hyperthermia, Cancer Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOCSystem, Rf/Microwave Hyperthermia, Cancer TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P820088016

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P820088016BSD 1000 HYPERTHERMIA SYSTEMPyrexar Medical, Inc.1983-11-28LOC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08644450004342PreviousGS10
00864445000434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
08644450004342086444500043428644450004342
00864445000434008644450004348644450004340864445000434

GMDN Terms#

Term, Definition table
TermDefinition
Microwave hyperthermia systemA mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)797-3927regulatory@pyrexar.com

Regulatory Flags#

DUNS number
079797900
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864445000403BSD-2000 Hyperthermia SystemBSD-2000B2023-07-18
00864445000441BSD-2000 Hyperthermia SystemBSD-2000U2023-07-18
08644450004038BSD-2000 Hyperthermia SystemBSD-2000B2023-05-24
08644450004106BSD-2000 Hyperthermia SystemBSD-2000U2023-05-24
08644450004342BSD-500 Hyperthermia SystemBSD-5002023-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08644450004342BSD-500 Hyperthermia SystemPyrexar Medical Inc.LOC2023-05-24
06971591765675Selethru NC PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOC2021-09-20
00851551005194BSD-500 Hyperthermia SystemBSD MEDICAL CORPORATIONLOC2014-09-24