Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/6105-1 |
| Registreeritud | 06.06.2024 |
| Sünkroonitud | 07.06.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-2 Kirjavahetus Eesti turule lastavatest/kasutusele võetavatest/levitatavatest seadmetest MSA kaudu teavitamiseks |
| Toimik | 11.1-2/2023 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Synopsys |
| Saabumis/saatmisviis | Synopsys |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Jessica James <[email protected]>
Sent: Mon, 27 Feb 2023 10:56:51 +0000
To: "[email protected]" <[email protected]>
Subject: notification of medical device - simpleware scanip medical
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear team,
Please find below information for registering the non-Estonian manufacturer Synopsys (Northern Europe) Ltd. and the software-only product Simpleware ScanIP Medical for the Estonian market:
Name and address of person responsible for placing a product on the Estonian market, responsible for distribution or put into service in Estonia:
Synopsys (Northern Europe) Ltd.
Bradninch Hall, Castle Street, Exeter, Devon, EX4 3PL, United Kingdom
+44 (0)1392 428750
Contact: Jessica James, [email protected]
The name and address of manufacturer of medical devices and, if applicable the name and address of authorised representative in the EU;
Manufacturer:
Synopsys (Northern Europe) Ltd.
Bradninch Hall, Castle Street, Exeter, Devon, EX4 3PL, United Kingdom
+44 (0)1392 428750
Authorised representative:
Synopsys International Ltd.
Blanchardstown Corp Park, Block 1, Dublin 15, Ireland
353-1-436-8800
Name and intended purpose of the device in Estonian and English:
Simpleware ScanIP Medical
Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or an MRI scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options. Simpleware ScanIP Medical is not intended to be used for mammography imaging.
Simpleware ScanIP Medical on ette nähtud kasutamiseks tarkvaraliidesena ja pildisegmentimise süsteemina kujutisandmete
ülekandmisel meditsiinilisest skannerist, nagu kompuutertomograafist või magnetresonantstomograafist, väljundfaili. See on ette
nähtud kasutamiseks ka tarkvarana kirurgiliste ravivõimaluste simuleerimisel/hindamisel enne operatsiooni. Simpleware ScanIP
Medical pole ette nähtud kasutamiseks mammograafias
Identification of the device (commercial name of the device, model or catalogue number):
Simpleware ScanIP Medical
Software-only device, covering versions:
O-2018.12
P-2019.09
Q-2020.03
Q-2020.06
R-2020.09
R-2021.03
S-2021.06
T-2022.03
Please let me know if any of this information is unclear, or if any more information is needed.
Best,
Jessica
Jessica James, PhD
Quality Management Representative, Simpleware Software
w +44 (0)1392 428752 | [email protected]
www.synopsys.com | Bradninch Hall, Castle Street, Exeter, EX4 3PL, UK
