Implant Sciences Corp. Model HDR 4454

Q: What is the product code of K070468?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.

FDA 510(k) K070468 · Implant Sciences Corp.

Substantially Equivalent

510(k) numberK070468

Submission

Device name: Implant Sciences Corp. Model HDR 4454
Applicant: Implant Sciences Corp.
Wakefield, MA, US
Received: February 16, 2007
Decision date: March 23, 2007
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KXK – Source, Brachytherapy, Radionuclide
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.5730
Specialty: Radiology
Implant: Yes

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More from Isoray Medical, Inc.

510(k)	Device	Decision
K042864	Implant Sciences Corp, Model HDR-4140KXK · Traditional	01/06/2005SE
K023073	Seed LinkKXK · Traditional	04/07/2003SE
K023242	I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-SterileKXK · Special	12/04/2002SE
K994317	I-Plant, Model 3500KXK · Traditional	03/21/2000SE
K990193	Iodine Brachytherapy Seeds, Model 3000KXK · Traditional	05/20/1999SE

Questions and answers

When was Implant Sciences Corp. Model HDR 4454 cleared by the FDA?

Implant Sciences Corp. Model HDR 4454 (K070468) received a 510(k) decision of Substantially Equivalent on March 23, 2007, 35 days after the submission was received.

What is the product code of K070468?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.