Biopsy needles
Atec Sapphire
An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.
Atec Sapphire models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| ATEC SAPPHIRE | — | MR Unsafe | Available |
FDA clearances
- 510(k) K042290 October 2004
Procedures that use biopsy needles
Frequently asked questions
What is Atec Sapphire used for?
An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.
Who makes Atec Sapphire?
Atec Sapphire is made by Hologic, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does Atec Sapphire come in?
The FDA device database does not list sizes for Atec Sapphire. Check the instructions for use or ask a Hologic, Inc. representative.
Is Atec Sapphire MRI safe?
The FDA device database lists Atec Sapphire as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Atec Sapphire FDA cleared?
Atec Sapphire is covered by FDA submission K042290.
How do I contact a Hologic, Inc. sales representative?
Hologic, Inc. has not listed representatives on LA Vascular yet. Visit the Hologic, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.