Siemens Medical Solutions USA, Inc

Product: syngo RT Therapist model/part #8162815 Product: syngo RT Therapist Assist model/part #8162807 Product: syngo RT Therapist Express Basic model/part #8151289 Product: syngo RT Therapist Express Assist model/part #8151289

Radiology Devices

2

No

Worldwide Distribution -- USA, Spain, Germany, Poland, Australia, Malaysia, New Zealand, the UK, India, Ireland, Egypt, Italy, Belgium, Republic of Korea, and Canada.

Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA

Part Number 8139789, Serial Numbers: 5190, 5350, 5355, 5364, 5367, 5374, 5377, 5398, 5405, 5410, 5419, 5424, 5165, 5166, 5202, 5238, 5298, 5306, 5342, 5352, 5365, 5366, 5373, 5378, 5379, 5380, 5397, 5399, 5400, 5401, 5402, 5409, 5414, 5416, 5423 and 5425.

Radiology Devices

2

No

Worldwide Distribution including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium, New Zealand, France, Malaysia, Spain, and Canada.

Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems, Concord, CA.

Part # 8139789, with Syngo RT Therapist version 4.1 build 67

Radiology Devices

2

No

Worldwide Distribution --- including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Belgium, France, New Zealand, Malaysia, Spain and Canada.

Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789, manufactured by Siemens Medical Solutions, Oncology Care System. || Intended use is to deliver x-ray radiation for therapeutic treatment of cancer.

Software Numbers 7358299, 7360857, and 8141835. Applies only to those parts used with the following devices: Coherence AG Therapist-5863506; Coherence Therapist System-7333680; Coherence Impression Therapist-7341410; PRIMEVIEW 3i-7341428; AG Therapist 3rd party V&R-7351898; Coherence Therapist 2.0-8139839 and PRIMEVIEW 3i 2.0-8139847.

Radiology Devices

2

No

Class II Recall - Worldwide Distribution --- including USA and countries of Angola, Australia, Brazil, Canada, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Iran, Italy, Japan, Malaysia, Netherlands, New Zealand, P.R. China, Poland, Portugal, Republic Korea, Russian, Fed. Saudi Arabia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad, Tobago, Turkey, United States, Vietnam.

Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH 030//07/S. The COHERENCE Therapist R2.0 software numbers are: 7358299, 7360857, and 8141835 and applies only to those parts used with the following devices: Coherence AG Therapist; Coherence Therapist System; Coherence Impression Therapist; PRIMEVIEW 3i; AG Therapist 3rd party V&R; Coherence Therapist 2.0 and PRIMEVIEW 3i 2.0.

Therapist Exoress Basis Part number 08515289 syngo Therapist Express Part Number 08162815 syngo RT Therapist Connect/ MOSAIQ OIS Part number 08168754.

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) including states of: CA, FL, OH, PA and UT; and countries including: Australia, Belgium, Croatia, Germany, Japan, South Africa, Sweden and United Kingdom.

ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2. || The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 software. The RT Oncologist v4.2 is currently only on Non-US systems. || Distributed by Siemens Healthcare, Concord, CA 94520 || Intended use: Radiation therapy