Multicare Platinum System and Accessories

FDA 510(k) K030666 · Lorad, A Hologic Co.

Substantially Equivalent

510(k) numberK030666

Submission

Device name
Multicare Platinum System and Accessories
Applicant
Lorad, A Hologic Co.
Danbury, CT, US
Received
March 3, 2003
Decision date
March 25, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZH – System, X-Ray, Mammographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1710
Specialty
Radiology

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More from Giotto USA, LLC

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Questions and answers

When was Multicare Platinum System and Accessories cleared by the FDA?

Multicare Platinum System and Accessories (K030666) received a 510(k) decision of Substantially Equivalent on March 25, 2003, 22 days after the submission was received.

What is the product code of K030666?

The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.