Atlas FDA

MEVATRON, M 2 CLASS

FDA 510(k) clearance K882729 · decided 1988-09-19

Clearance details

K-number
K882729
Device name
MEVATRON, M 2 CLASS
Applicant
Siemens Medical Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1988-07-06
Decision date
1988-09-19
Days to decision
75 days
Clearance type
Traditional
Product code
IYE
Device class
2
Regulation number
892.5050
Medical specialty
Radiology
Advisory committee
Radiology
Location
Walnut Creek, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Mevatron M2/PRIMUS Mid; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEV recall (Z-0780-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron K2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linea recall (Z-0781-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron 77; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linea recall (Z-0783-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M 7400/7440 (MXE); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and recall (Z-0784-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron 67; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linea recall (Z-0785-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M 6700 (MX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVAT recall (Z-0786-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M 6300 (MX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVAT recall (Z-0787-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M 6730/6740; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVAT recall (Z-0788-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron MD (MD, MDX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVA recall (Z-0789-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron KD; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linea recall (Z-0790-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron ME; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linea recall (Z-0791-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron KD2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Line recall (Z-0792-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M2 6300; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON recall (Z-0793-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron M2 6740; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON recall (Z-0794-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron MD-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Lin recall (Z-0795-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron KDS-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Li recall (Z-0796-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron KD-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Lin recall (Z-0797-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron KDS-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Li recall (Z-0798-2012)Siemens Medical Solutions USA, Inc2012-01-17
Mevatron KD-2 Medical Linear Accelerator, Material Number: 8515520, with control console s recall (Z-1401-2008)Siemens Medical Solutions USA, Inc2008-04-02
Mevatron KDS-2 Medical Linear Accelerator, Material Number: 9822693, with control console recall (Z-1402-2008)Siemens Medical Solutions USA, Inc2008-04-02
Siemens Mevatron Linear Accelerator Systems; Mevatron M 7440, Part No.: 5672977; Mevatron recall (Z-0852-2008)Siemens Medical Solutions USA, Inc2008-02-19
Siemens Mevatron MD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw recall (Z-0678-2008)Siemens Medical Solutions USA, Inc2008-02-14
Siemens Mevatron M-2 6740 Medical Charged-Particle Radiation Therapy System; (Interlock #5 recall (Z-0679-2008)Siemens Medical Solutions USA, Inc2008-02-14
Siemens Mevatron MDX-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 J recall (Z-0682-2008)Siemens Medical Solutions USA, Inc2008-02-14
Seimens Mevatron M-2 6700 Medical Charged-Particle Radiation Therapy System; (Interlock #5 recall (Z-0683-2008)Siemens Medical Solutions USA, Inc2008-02-14
Seimens Mevatron M-2 6300 Medical Charged-Particle Radiation Therapy System; (Interlock #5 recall (Z-0684-2008)Siemens Medical Solutions USA, Inc2008-02-14
MEVATRON KD2,Medical charge-particle radiation therapy system (Medical Digital Linear Acce recall (Z-0155-2008)Siemens Medical Solutions USA, Inc2007-11-09
MEVATRON KD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Acc recall (Z-0156-2008)Siemens Medical Solutions USA, Inc2007-11-09
MEVATRON KDS,Medical charge-particle radiation therapy system (Medical Digital Linear Acce recall (Z-0157-2008)Siemens Medical Solutions USA, Inc2007-11-09
MEVATRON KDS-2,Medical charge-particle radiation therapy system (Medical Digital Linear Ac recall (Z-0158-2008)Siemens Medical Solutions USA, Inc2007-11-09
MEVATRON M-2 6300,Medical charge-particle radiation therapy system (Medical Digital Linear recall (Z-0159-2008)Siemens Medical Solutions USA, Inc2007-11-09
MEVATRON M-2 6700,Medical charge-particle radiation therapy system (Medical Digital Linear recall (Z-0160-2008)Siemens Medical Solutions USA, Inc2007-11-09
MEVATRON M-2 6740,Medical charge-particle radiation therapy system (Medical Digital Linear recall (Z-0161-2008)Siemens Medical Solutions USA, Inc2007-11-09
MEVATRON MD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Acc recall (Z-0162-2008)Siemens Medical Solutions USA, Inc2007-11-09
MEVATRON MDX-2,Medical charge-particle radiation therapy system (Medical Digital Linear Ac recall (Z-0163-2008)Siemens Medical Solutions USA, Inc2007-11-09