Biopsy needles
ATEC Sapphire 200
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 200 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 200 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K042290 October 2004
Procedures that use biopsy needles
Frequently asked questions
What is ATEC Sapphire 200 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 200?
ATEC Sapphire 200 is made by Hologic, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does ATEC Sapphire 200 come in?
The FDA device database does not list sizes for ATEC Sapphire 200. Check the instructions for use or ask a Hologic, Inc. representative.
Is ATEC Sapphire 200 MRI safe?
The FDA device database lists ATEC Sapphire 200 as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is ATEC Sapphire 200 FDA cleared?
ATEC Sapphire 200 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.