(26 days)
No
The summary mentions "image processing capability" but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description focuses on standard digital radiography components and functionality.
No
The device is described as a "diagnostic x-ray system" used for the "generation of x-rays for examination of various anatomical regions," indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions."
No
The device description clearly states it is a diagnostic x-ray system consisting of multiple hardware components (generator, tube crane, table, wall stand, PC, etc.), not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "diagnostic x-ray system for generation of x-rays for examination of various anatomical regions." This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description details components like an x-ray generator, tube crane, table, and wall stand, all characteristic of an external imaging system.
- Input Imaging Modality: The input modality is "x-ray," which is an external imaging technique, not a test performed on biological samples.
- Anatomical Site: It examines "various anatomical regions" of the body, not biological samples.
IVD devices are designed to perform tests on biological samples (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests. It generates images of the body.
N/A
Intended Use / Indications for Use
The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Product codes
KPR
Device Description
The DRX-Evolution is a diagnostic x-ray system utilizing digital radiography (DR) technology. The DRX-Evolution is designed for horizontal and upright projections. It consists of a high frequency x-ray generator, overhead tube crane (with x-ray tube assembly), elevating 4-way float radiographic table with detector tray, tilting Bucky receptor on an upright Wall Stand, and x-ray controls containing a power distribution unit and operator PC. The DRX-Evolution incorporates the following new features:
- Add the wireless Carestream DRX-1 System detector option as a component of the x-ray system
- Include a different model CPI generator
- Add a Toshiba x-ray tube option (tube used in predicate device (K051258) still available)
- Include Carestream- designed motion control software that functions the same as the OEM-designed motion control software used in the predicate device (K051258).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
various anatomical regions.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. Nonclinical testing was conducted under simulated use conditions. Predefined acceptance criteria was met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Special 510(k) for DRX-Evolution
KC091889
Image /page/0/Picture/2 description: The image shows the logo for Carestream Health. The logo consists of the word "Carestream" in a sans-serif font, with the word "HEALTH" in a smaller font below it. To the right of the word "Carestream" is a stylized graphic that appears to be a circle with some internal shapes.
JUL 2 0 2009
"510(k) Summary"
510(k) Owner Name: 510(k) Owner Address:
510(k) Owner Phone: 510(k) Owner Fax:
Contact Person & Info:
Carestream Health, Inc. 150 Verona Street Rochester, New York 14608
585 627-6543 585 454-1894
Carolyn Wagner Regulatory Affairs Manager, Medical Imaging carolyn.wagner@carestreamhealth.com 585-627-6588
Date Summary Prepared:
Device Trade Name: Device Common Name: Classification Name:
Device Class: Device Code: Regulation Number:
Predicate Devices:
May 20, 2009
DRX-Evolution diagnostic x-ray system Stationary x-ray system
Class II 90 KPR 21 CFR 892,1680
Kodak DirectView DR 7500 Manufactured by Carestream Health, Inc. 510(k) No. - K051258 (June 1, 2005) AND Carestream DRX-1 System Manufactured by CarestreamHealth, Inc. . 510(k) No. - K090318 (April 6, 2009)
Device Description:
The DRX-Evolution is a diagnostic x-ray system utilizing digital radiography (DR) technology. The DRX-Evolution is designed for horizontal and upright projections. It consists of a high frequency x-ray generator, overhead tube crane (with x-ray tube assembly), elevating 4-way float radiographic table with detector tray, tilting Bucky receptor on an upright Wall Stand, and x-ray controls containing a power distribution unit and operator PC. The DRX-Evolution incorporates the following new features:
1
- Add the wireless Carestream DRX-1 System detector option as a component of 하 the x-ray system
- Include a different model CPI generator ■
- Add a Toshiba x-ray tube option (tube used in predicate device (K051258) still . available)
- Include Carestream- designed motion control software that functions the same as 트 the OEM-designed motion control software used in the predicate device (K051258).
Intended Use:
The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Comparison of Technological Characteristics:
The DRX-Evolution has the same technological characteristics as the predicate device, the Kodak DirectView DR 7500 System. The DRX-Evolution System incorporates various configurations with the following standard components: radiographic table, flat panel detector, x-ray generator, x-ray tube housing, and beam-limiting device. The device modifications raise no new issues of safety or effectiveness.
Discussion of Testing
Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. Nonclinical testing was conducted under simulated use conditions. Predefined acceptance criteria was met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
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Substantial Equivalence Comparison with Predicate Devices
:
| Kodak DirectView DR 5100 | Kodak DirectView DR 7100 | Kodak DirectView DR 7500 | DRX-Evolution | |
|---|---|---|---|---|
| DR System | K001341 | K001341 | K051258 (SE to Kodak DirectView DR 5100/7100) | SE to Kodak DirectView DR (K051258) and Carestream DRX-1 System (K090318) |
| Image Processing | ||||
| Software | K925344 | K925344 | K925344, K060137 | K060137 |
| Long Length Imaging | ||||
| Software | No | No | K081836 | K081836 |
| Intended Use & | ||||
| Indications for Use | Permanently installed diagnostic x-ray | |||
| system for generation of x-rays for | ||||
| examinations of various anatomical | ||||
| regions. | Permanently installed diagnostic x-ray | |||
| system for generation of x-rays for | ||||
| examinations of various anatomical | ||||
| regions. | Permanently installed diagnostic x-ray | |||
| system for generation of x-rays for | ||||
| examinations of various anatomical | ||||
| regions. | Permanently installed diagnostic x-ray | |||
| system for generation of x-rays for | ||||
| examinations of various anatomical | ||||
| regions. | ||||
| X-ray Generator | Communication Power Industries | |||
| Indico 100 Series X-ray Generator | Communication Power Industries | |||
| Indico 100 Series X-ray Generator | Communication Power Industries | |||
| Indico 100 Series X-ray Generator | Communication Power Industries | |||
| CMP200DR X-ray Generator | ||||
| X-ray Tube | Varian X-ray Tube (RAD-60 w/ B-130 housing) | Varian X-ray Tube (RAD-60 w/ B-130 housing) | Varian X-ray Tube (RAD-60 w/ B-130 housing) | Varian X-ray Tube (RAD-60 w/ B-130 housing) / Alternate: Toshiba |
| E7254GX with XH-157 Housing | ||||
| Beam Limiting Device | Collimator: Huestis Medical Model | |||
| 150 PBL | Collimator: Huestis Medical Model | |||
| 150 PBL | Collimator: Ralco, Model 302 ACS. | |||
| Collimator K / Alternate: Ralco R302 | ||||
| DACS/A | Ralco R302 DACS/A | |||
| Detector | ||||
| (X-ray Operator Console) | DirectRay Digital Array & Controller | |||
| (Solid State Digital Device, K973206) | DirectRay Digital Array & Controller | |||
| (Solid State Digital Device, K973206) | DirectRay Digital Array & Controller | |||
| (Solid State Digital Device, K973206)/ Carestream DRX-1 Digital Detector | ||||
| (K090318)/ Alternate: Trixell Pixium 4600 Digital | ||||
| Detector | Carestream DRX-1 Digital Detector | |||
| (K090318) / Alternate: Trixell Pixium | ||||
| 4600 Digital Detector | ||||
| Operator Console (X-ray | ||||
| control) | Diagnostic Operator Console | |||
| System software w/ image | ||||
| processing capability | ||||
| Computer w/ touch screen | ||||
| monitor | ||||
| Barcode Scanner | Diagnostic Operator Console | |||
| System software w/ image | ||||
| processing capability | ||||
| Computer w/ touch screen | ||||
| monitor | ||||
| Barcode Scanner | Diagnostic Operator Console | |||
| System software w/ image | ||||
| processing capability | ||||
| Computer w/ touch screen | ||||
| monitor | ||||
| Barcode Scanner | Diagnostic Operator Console | |||
| System software w/ image | ||||
| processing capability | ||||
| Computer w/ touch screen | ||||
| monitor | ||||
| Barcode Scanner | ||||
| Timing Distribution Unit | ||||
| (X-ray control) | Timing and Distribution Unit: Best | |||
| Power Fortress 750 UPS | Timing and Distribution Unit: Best | |||
| Power Fortress 750 UPS | Timing and Distribution Unit (provides | |||
| generator interface & power | ||||
| distribution): Best Power Fortress 750 | ||||
| UPS/Alternate: APC 1500 VA UPS | Power Distribution Unit (provides | |||
| power distribution & generator | ||||
| interface): Optional APC 1500 VA | ||||
| UPS | ||||
| Overhead Tube Crane / | ||||
| Tube Stand | ||||
| Wall Stand | Tube Stand w/ manual and automated | |||
| ray tube assembly movement | ||||
| Yes, contains Bucky w/ Detector | Overhead Tube Crane w/ manual x-ray | |||
| tube assembly movement | ||||
| No | x-Overhead Tube Crane w/ manual and | |||
| automated x-ray tube assembly | ||||
| movement | ||||
| Yes, contains Bucky w/ Detector | Overhead Tube Crane w/ manual and | |||
| automated x-ray tube assembly | ||||
| movement | ||||
| Yes, contains Bucky w/ Detector |
.
.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 2009
Ms. Carolyn L. Wagner, RAC Regulatory Affairs Manager Carestream Health, Inc. 150 Verona Street ROCHESTER NY 14608
Re: K091889
Trade/Device Name: DRX-Evolution Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 23, 2009 Received: June 24, 2009
Dear Ms. Wagner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical
4
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Special 510(k): Carestream Health, Inc.
Statement of Intended Use
510(k) Number (if known):
Device Name:
DRX-Evolution
Indications for Use:
The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Prescription Use_ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heidi Reem
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number