Lorad, A Hologic Co.
Country not established
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Lorad, A Hologic Co. makes
Lorad manufactures mammography systems, including modified digital and analog models like the M-IV and 650 series, as well as breast biopsy guidance systems such as the Affirm. Their portfolio also includes the Multicare Platinum system and associated accessories for imaging and diagnostic procedures.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Modified M-Iv Mammography System Ref K011987
Regimes: 510(k) Registry: 510(k)Digital Stereoloc Ii Ref K071542
Regimes: 510(k) Registry: 510(k)Modified 650 Mammography System Ref K013290
Regimes: 510(k) Registry: 510(k)Multicare Platinum System And Accessories Ref K030666
Regimes: 510(k) Registry: 510(k)Affirm Breast Biopsy Guidance System Ref K122836
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Lorad, A Hologic Co., initiated on 2008-02-28. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 28 Feb 2008 Z-1546-2008 Unclassified (pre-2012) Terminated Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indication.
Frequently asked questions
How many devices does Lorad, A Hologic Co. have in the registry?
The registry currently lists 5 devices for Lorad, A Hologic Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lorad, A Hologic Co.'s devices?
Among its 5 most recently registered devices, Lorad, A Hologic Co. has devices listed in FDA 510(k) (5 devices).
What risk classes do Lorad, A Hologic Co.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Lorad, A Hologic Co.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Lorad, A Hologic Co.?
FDA recall records list 1 recall initiated by Lorad, A Hologic Co., the most recent initiated on 28 Feb 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Lorad, A Hologic Co. in the registry?
The most recently registered devices listed for Lorad, A Hologic Co. include MODIFIED M-IV MAMMOGRAPHY SYSTEM, DIGITAL STEREOLOC II, MODIFIED 650 MAMMOGRAPHY SYSTEM and MULTICARE PLATINUM SYSTEM AND ACCESSORIES.