Northwest Medical Physics Equipment, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 7
At a glance
Market reach
- United States
- FDA recalls
What Northwest Medical Physics Equipment, Inc. makes
Northwest Medical Physics Equipment, Inc. manufactures medical imaging and radiation therapy devices, including the ACCULOC Breast Localization System for precise breast biopsy targeting, treatment planning software (P REFERENCE TPS 1.1), and specialized modules like the PREFERENCE IMRT Treatment Planning Module for intensity-modulated radiation therapy. The company also provides the MRTOFLM computer program for treatment verification and the PREFERENCE Treatment System for radiotherapy workflow management.
The company’s portfolio consists of Class II medical devices, all of which are subject to FDA 510(k) clearance requirements. These devices are listed under the FDA’s 510(k) regulatory pathway, ensuring compliance with U.S. medical device regulations. The company operates from the United States.
Catalogue
Acculoc Breast Localization System Ref K063274
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Preference Treatment System Ref K983793
Regimes: 510(k) Registry: 510(k)Prefernce Imrt Treatment Planning Module Ref K012575
Regimes: 510(k) Registry: 510(k)Mrtoflm Computer Program Ref K960293
Regimes: 510(k) Registry: 510(k)Preference Treatment System Ref K001833
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 7 recalls initiated by Northwest Medical Physics Equipment, Inc., the earliest on 2004-11-30 and the most recent on 2006-04-07. By recorded status: 7 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.
2006
- 7 Apr 2006 Z-1146-2007 Unclassified (pre-2012) Terminated This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.
- 2 Jan 2006 Z-1145-2007 Unclassified (pre-2012) Terminated Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.
2005
- 31 May 2005 Z-1147-2007 Unclassified (pre-2012) Terminated When the ISOLOC (Version 4.2) profile distance unit is set to "centimeter" and the user clicked the "back" button in the digitizer window, the marker and target coordinates in the localization window erroneously display values ten times greater than the correct values.
- 28 Apr 2005 Z-1152-2007 Unclassified (pre-2012) Terminated When ISOLOC version 6.0 and 4.2 distance unit is set to centimeter, the localization coordinates were rounded to the nearest millimeter which could affect positioning by 0.5 mm.
- 11 Apr 2005 Z-1153-2007 Unclassified (pre-2012) Terminated When ISOLOC version 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 0.5 mm.
2004
- 30 Dec 2004 Z-1154-2007 Unclassified (pre-2012) Terminated When ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.
- 30 Nov 2004 Z-1155-2007 Unclassified (pre-2012) Terminated When ISOLOC Version 4.2 unit is set to centimeter and the user clicks the Reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously displays values ten times greater than the correct values.
Frequently asked questions
How many devices does Northwest Medical Physics Equipment, Inc. have in the registry?
The registry currently lists 6 devices for Northwest Medical Physics Equipment, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Northwest Medical Physics Equipment, Inc.'s devices?
Among its 6 most recently registered devices, Northwest Medical Physics Equipment, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Northwest Medical Physics Equipment, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Northwest Medical Physics Equipment, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Northwest Medical Physics Equipment, Inc.?
FDA recall records list 7 recalls initiated by Northwest Medical Physics Equipment, Inc., the most recent initiated on 7 Apr 2006. 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 Northwest Medical Physics Equipment, Inc. in the registry?
The most recently registered devices listed for Northwest Medical Physics Equipment, Inc. include ACCULOC BREAST LOCALIZATION SYSTEM, P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1, PREFERENCE TREATMENT SYSTEM and PREFERNCE IMRT TREATMENT PLANNING MODULE.