510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Northwest Medical Physics Equipment, Inc.

Lynnwood, WA, US

Northwest Medical Physics Equipment, Inc. appears in FDA device records in Lynnwood, WA. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 7 recalls for this company.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
7
Registered establishments
0

510(k) clearance history

FDA records hold 6 510(k) clearances for Northwest Medical Physics Equipment, Inc. between 1996 and 2006. The busiest year on record is 1996, with 1. The most recent is 2006, with 1.

Clearances by year, as a table
510(k) clearance decisions for Northwest Medical Physics Equipment, Inc., by decision year
YearClearances
19961
19971
19991
20001
20021
20061
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K063274ACCULOC BREAST LOCALIZATION SYSTEMIYESubstantially Equivalent
K012575PREFERNCE IMRT TREATMENT PLANNING MODULEMUJSubstantially Equivalent
K001833PREFERENCE TREATMENT SYSTEMIYESubstantially Equivalent
K983793PREFERENCE TREATMENT SYSTEMLNHSubstantially Equivalent
K970464P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1IYESubstantially Equivalent
K960293MRTOFLM COMPUTER PROGRAMIYESubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1146-2007ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.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.Terminated
Z-1145-2007Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-425-520. Software for image guided radiation therapy.Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.Terminated
Z-1147-2007ISOLOC 4.2 Software Part Number NT-NW-425-520. Image guided radiation treatment software.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.Terminated
Z-1152-2007ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software.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.Terminated
Z-1153-2007ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for high accuracy radiotherapy.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.Terminated
Z-1154-2007ISOLOC Software Version 6.0, Part Number NT-NW-425-520. Localization software for radiotherapy treatment system.When ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.Terminated
Z-1155-2007ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software.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.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain