MAX-1000A/R1
by Toshiba America Medical Systems, In.C
510(k) K954590
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954590 | Date20 Nov 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JAA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Max-1000A/R1 is an image-intensified, fluoroscopic X-ray system. It is classified as a radiology device designed for diagnostic imaging applications.
This device is manufactured by Toshiba America Medical Systems, Inc. and received FDA 510(k) clearance under the traditional pathway.
Other devices from Toshiba America Medical Systems, In.C
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Questions
AI-generated answers, 23 Sep 2026
What is the primary use of the MAX-1000A/R1?
The MAX-1000A/R1 is a radiology device specifically designed for diagnostic imaging applications using image-intensified, fluoroscopic X-ray technology.
What is the regulatory status of this device?
The MAX-1000A/R1 received FDA 510(k) clearance under the traditional pathway, as indicated by the decision summary K954590.
Who is the manufacturer of this system?
This device is manufactured by Toshiba America Medical Systems, Inc., located in Tustin, California.