Atlas FDA

COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM

FDA 510(k) clearance K940484 · decided 1994-04-19

Clearance details

K-number
K940484
Device name
COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
1994-02-02
Decision date
1994-04-19
Days to decision
76 days
Clearance type
Traditional
Product code
IZI
Device class
2
Regulation number
892.1600
Medical specialty
Radiology
Advisory committee
Radiology
Location
Iselin, NJ, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Siemens Medical Solutions USA

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
780 nm SPY Portable Handheld Imaging (SPY-PHI) System (K261037)Stryker Endoscopy2026-05-28
SURGIMAGE SIM 1000H Fluorescence Imaging Platform (K253181)Surgimage Corporation2026-05-13
IC-Flow™ Imaging System 2.0 (K243645)Diagnostic Green GmbH2025-09-22
Affirm 800 (K243077)Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)2025-06-27
Modus IR (K231986)Synaptive Medical, Inc.2024-03-25
EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (K234090)Surgvision GmbH2024-03-20
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (K231075)Carl Zeiss Meditec, Inc.2023-06-20
SPY Portable Handheld Imaging (SPY-PHI) System (K230727)Novadaq Technologies Ulc (A Part of Stryker)2023-06-05
EXPLORER AIR® II (K222240)Surgvision GmbH2023-02-28
Explorer Air II (K214097)Surgvision GmbH2022-02-25
DIR 800 (K202391)Aesculap, Inc.2021-01-21
Asimov-MKS Imaging System (K192761)Onlume, Inc.2020-01-17

Recalls involving this device

RecordFirmDate
Coroskop X-Ray System, Model numbers 6258219 and 6379759. recall (Z-0136-2009)Siemens Medical Solutions USA, Inc2008-11-04
Bicor X-Ray System, Model number 9023136. recall (Z-0137-2009)Siemens Medical Solutions USA, Inc2008-11-04
Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383. recall (Z-0138-2009)Siemens Medical Solutions USA, Inc2008-11-04
Coroskop Top X-Ray System, Model number 6134808. recall (Z-0140-2009)Siemens Medical Solutions USA, Inc2008-11-04
Coroskop C X-Ray System, Model numbers 6005636 and 9108572. recall (Z-0141-2009)Siemens Medical Solutions USA, Inc2008-11-04
BICOR HS X-Ray System, Model number 6005776 recall (Z-0143-2009)Siemens Medical Solutions USA, Inc2008-11-04
COROSKOP HS-ACS X-Ray System, Model number 6134659. recall (Z-0144-2009)Siemens Medical Solutions USA, Inc2008-11-04
BICOR POLYDOROS X-Ray System, Model number 6134667. recall (Z-0145-2009)Siemens Medical Solutions USA, Inc2008-11-04
BICOR TOP X-Ray System, Model number 6134816. recall (Z-0146-2009)Siemens Medical Solutions USA, Inc2008-11-04

PMA approvals by this applicant

RecordFirmDate
MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008)Siemens Medical Solutions USA, Inc.2024-09-23
MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007)Siemens Medical Solutions USA, Inc.2020-08-21
MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006)Siemens Medical Solutions USA, Inc.2019-12-10
Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005)Siemens Medical Solutions USA, Inc.2017-09-29
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003)Siemens Medical Solutions USA, Inc.2017-03-23
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001)Siemens Medical Solutions USA, Inc.2016-05-12
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002)Siemens Medical Solutions USA, Inc.2016-01-13
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011)Siemens Medical Solutions USA, Inc.2015-04-21