(21 days)
Not Found
No
The document describes standard digital X-ray image acquisition and processing, with no mention of AI, ML, or related concepts. The image processing mentioned is typical for digital radiography systems and does not imply AI/ML.
No
The device is described as an X-ray imaging system for diagnostic purposes, used to generate and process images, not to provide therapy or treatment.
Yes
The device generates X-ray images for general radiography, which are used by healthcare professionals to look for and identify medical conditions, thereby aiding in diagnosis.
No
The device description explicitly states it includes hardware components such as a digital detector, X-ray generator interface, image acquisition workstation (including monitor, keyboard, mouse, computer, electronics), and a switch box.
Based on the provided information, the Saturn 9000-750 system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Saturn 9000-750 Function: The Saturn 9000-750 system generates digital X-ray images. This is an in vivo imaging technique, meaning it is performed on a living organism (the patient) directly, not on a sample taken from the body.
- Intended Use: The intended use clearly states it's for "general X-ray system" and "used in same clinical application as traditional film-screen based general radiography system." This aligns with diagnostic imaging, not in vitro testing.
Therefore, the Saturn 9000-750 is a medical imaging device, specifically a digital radiography system, and does not fall under the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Saturn 9000-750 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-750 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-750 is intended to be used in same clinical application as traditional film-screen based general radiography system.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The Saturn 9000-750 is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the X-ray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-750 includes acquisition workstation ("AWB") monitor, keyboard and mouse, computer, electronics, and accessory storage resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming,
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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510(K) Summary
Image /page/0/Picture/1 description: The image shows handwritten text. The text at the top reads "K072983". Below that, there is additional text that says "Page 2". The handwriting is somewhat cursive and appears to be on a document.
Image /page/0/Picture/2 description: The image shows a large, stylized letter 'N'. The letter is bold and appears to be slightly tilted to the right. The texture of the letter is somewhat rough or grainy, giving it a textured appearance. The background is plain and white, which makes the letter stand out.
October 7th 2007 1. Date Prepared:
NOV 1 3 2007
2. Submitter:
New Medical Co.,LTD. Company Name: Company Address: 4F, No.42, SingZhong Rd., NeiHu District Taipei 114, Taiwan Young-Hoon Shin, Diretor of R&D, yhshin@newmedical.com.tw Contact Person: +886-2-8791-6268 Phone number: +886-2-8791-6269 FAX number:
3. Proposed Device:
| Type of the Submission: | Special |
|---|---|
| Reason For 510(k): | Replacement of the component |
| Manufacturer: | New Medical Co.,LTD |
| Trade Name: | New Medical |
| Model Name: | Saturn 9000-750 |
| Regulatory Class: | II |
| Classification Name: | MQB, Solid State X-ray Imager |
| FDA 510(K) Number: | To be assigned |
-
- Predicate Device:
| Manufacturer: | New Medical Co.,LTD. |
|---|---|
| Trade Name: | New Medical |
| Model Name: | Saturn 9000 |
| Regulatory Class: | II |
| Classification Name: | MQB, Solid State X-ray Imager |
| FDA 510(K) Number: | K063710 |
- Device Description: The Saturn 9000-750 is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the Xray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-750 includes acquisition workstation ("AWB") monitor,
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Koy Davis
Page 2 of 2.
keyboard and mouse, computer, electronics, and accessory storage resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming,
The Saturn 9000-750 is substantially equivalent to the Saturn 9000.
-
- Indications for Use: The Saturn 9000-750 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-750 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-750 is intended to be used in same clinical application as traditional film-screen based general radiography system.
7. Comparison between Predicate Device and Proposed Device
| | | Predicate Device
Saturn 9000 | Proposed Device
Saturn 9000-750 |
|----------------------------|-----------------------|---------------------------------|------------------------------------|
| Detector | Technology | a-Se, Direct | a-Se, Direct |
| | Thickness of Se layer | 450μm | 450μm |
| | Imaging Area | 14" X 17" | 17" X 17" |
| | Detector Pixel size | 139μm | 168μm |
| | Image Bit Depth | 14bits | 14bits |
| | Image Data Interface | Camera Link | Camera Link |
| Control Box | | | Same as Saturn 9000 |
| Switch Box | | | Same as Saturn 9000 |
| Image Acquisition software | | DxWorks | DxWorks
(Same as Saturn 9000) |
| Accessories | | | Same as Saturn 9000 |
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a flame.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Mr. Young-Hoon Shin Director of R&D New Medical Company. Ltd. 4F, No. 42, SingZhong Road NEIHU DISTRICT TAIPEI TAIWAN
Re: K072983
Trade/Device Name: Saturn 9000-750 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 19, 2007 Received: October 23, 2007
AUG 2 3 2013
Dear Mr. Shin:
This letter corrects our substantially equivalent letter of November 13, 2007.
We have reviewed your Section 510(k) premarket notification of intent to market the indication indication we have reviewed your Section 910(x) premation is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosult, to tegary manates produced Device Amendments, or to commerce prior in May 28, 1970, the enactions and othe provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The You may, merelore, market the devices, secolor of the ments for annual registration, listing of general controls provisions of the rice labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such II your device is Classified (Sec above) into case (S) (S) = (S) = (S) = (S) = (S) = (S) = (S) = (S) = (S) = (S) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further Sour of recents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a stablice complies with other requiremes of the Act that FDA has made a decorminations administered by other Federal agencies. You must of any Federal Statutes and regulations adminities on on limited to: registration and listing (21 Configure and an the Act 31equirements, art. and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality >>steam ( (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CIONTINUE ON ANOTHER PAGE IF needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Stb. Ofc
ductive, Abdominal and 510/k) Number
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