(28 days)
No
The summary describes a digitizing scanner with basic image processing capabilities (display, processing, compression) on a standard PC, with no mention of AI, ML, or related concepts.
No.
The device is an image digitizer, which processes radiographic images for display, archiving, or transmission, and does not directly treat or diagnose a disease or condition.
No
The device is described as an "image digitizer" that converts images from phosphor plates to a digital format for display, processing, or archiving. It explicitly states, "This device is not to be used for primary imaging diagnosis in mammography," which indicates it is not intended for diagnostic purposes. Its function is to digitize existing images, not to interpret or diagnose from them.
No
The device description clearly outlines hardware components like a laser beam, fiber optics, a stepping motor, and an internal computer, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "image digitizer intended to produce digital copies of phosphor plate recorded images." It is used to convert existing radiographic images into a digital format for display, processing, archiving, or transmission.
- Device Description: The description reinforces this by explaining how it scans and digitizes radiographic film transparency images.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens. It processes images that were previously created from a patient.
The device is a medical image processing and management device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CR-Pro is a free standing, laser driven, image digitizer intended to produce digital copies of phosphor plate recorded images in 16 levels of gray scale. The digital copies are transmitted to an internal Intel Pentium 4 based personal computer (PC) where they may be displayed, processed, or compressed for archiving or transmission via computer networks to other medical facility sites.
This device is not to be used for primary imaging diagnosis in mammography.
Product codes
MQB
Device Description
The eRadlink CR-Pro is a digitizing scanner that converts radiographic film transparency images to digital format. This is accomplished by utilizing a laser beam light source and a proprietary sealed path of fiber optics. The new technology provides superior image quality, requires no internal optics cleaning, no optical alignment and is inherently highly accurate and reliable.
Phosphor plates from a minimum of 10 inches to a maximum of 14 inches in width, is driven past the digitizing laser beam by a clocked, stepping motor. Scanned data is electronically converted from analog to 16 bit digital gray scale and transmitted to the internal computer for processing.
Mentions image processing
Scanned data is electronically converted from analog to 16 bit digital gray scale and transmitted to the internal computer for processing.
The digital copies are transmitted to an internal Intel Pentium 4 based personal computer (PC) where they may be displayed, processed, or compressed for archiving or transmission via computer networks to other medical facility sites.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Program testing and calibration using Beryllium gray-scale wedge, body part phantoms and typical x-ray plate samples has demonstrated the CR-Pro's conformance to its defined specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OREX PcCR (K003256)
Reference Device(s)
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
1052938
NOV 1 7 2005
Per Title 21 CFR 807. 92, the following is the 510(k) Summary for the Solid State X-ray Imager manufactured and marketed by eRadlink Inc. under the trade-name eRadlink CR-Pro:
- eRadlink Inc. SUBMITTER: (1) 22760 Hawthorne Blvd. Torrance, California 90505-3664 Phone: 310-373-5673 310-373-9763 Fax:
Albert Kouba CONTACT: Manager, Regulatory Affairs 22760 Hawthorne Blvd. Torrance, California 90505-3664 Phone: 310-373-5673 310-373-9763 Fax:
30 September 2005 SUBMISSION DATE:
DEVICE NAME: (2)
ﺴ
| TRADE NAME: | eRadlink CR-Pro |
|---|---|
| COMMON NAME: | Storage Phosphor Reader with Software Modification |
| CLASSIFICATION NAME: | Solid State X-ray Imager (per regulation 21 CFR 892.1650) |
| (Class II device) | |
| PRODUCT CODE: | MQB |
| (3) PREDICATE DEVICE: | OREX PcCR (K003256) |
| 49 Plain St. | |
| Attleboro, MA 02760 |
DEVICE DESCRIPTION: (4)
The eRadlink CR-Pro is a digitizing scanner that converts radiographic film transparency images to digital format. This is accomplished by utilizing a laser beam light source and a proprietary sealed path of fiber optics. The new technology provides superior image quality, requires no internal optics cleaning, no optical alignment and is inherently highly accurate and reliable.
Phosphor plates from a minimum of 10 inches to a maximum of 14 inches in width, is driven past the digitizing laser beam by a clocked, stepping motor. Scanned data is electronically converted from analog to 16 bit digital gray scale and transmitted to the internal computer for processing.
INTENDED USE OF DEVICE (5)
The CR-Pro is a free standing, laser driven, image digitizer intended to produce digital copies of phosphor plate recorded images in 16 levels of gray scale. The digital copies are transmitted to an internal Intel Pentium 4 based personal computer (PC) where they may be displayed,
1
processed, or compressed for archiving or transmission via computer networks to other medical facility sites.
This device is not to be used for primary imaging diagnosis in mammography.
SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE - HARDWARE (6)
Table -- A illustrates the comparative equivalence of the CR-Pro to the Predicate device Hardware.
| Feature | eRadlink | OREX |
|---|---|---|
| Product Name | CR-Pro | PcCR |
| 510(k) Number | Not Issued | K003256 |
| Dimensions | 40in (h) x 24in(w) x 18in(d) | 16"(h) x 21"(w) x 29"(d) |
| Weight | 98lbs (44.5kg) | 90 lbs. (40.9 kg) |
| Power | 90-227vac 10A 47-63Hz | 110-120vac 1A 50/60 Hz |
| Scan Size | 8" x 10" (min) 14"x 17" (max) | 7" x 7" (min), 14" x 36" |
| Spot Size | 100μm | 100 μm |
| Dynamic Range | 0.0 - 3.5 OD | 0.5 - 3.8 OD |
| Gray Scale | 16 (Transmitted) | 8 or 12 bits |
| Digitizing Rate | 100 lines/sec | 115 lines/sec |
| Laser | 35 mw Solid State | He-Ne Laser |
| Beam Scan | Fiber Optics | Galvanometer |
| Pixel/mm | 8.0 | 10.09 |
| Plate Size | 14" x 17" | 14" x 17" |
| 14" x 14" | 14" x 14" | |
| 10" x 12" | 10" x 12" | |
| 8" x 10" | 8" x 10" | |
| Interface | USB 2 (Diagnostic), Ethernet | USB 1.1 |
| Computer | Pentium 4 2.8 GHz | Pentium 4 1.8 GHz |
| Ram | 512 MB | 512 MB |
| Hard Drive | 80GB | 20 GB |
| Video Card | 2 MB 1024 X 760 Resolution | 1024 X 760 Resolution |
| Monitor | 1024 x 760 | 1024 x 760 |
| Operating System | Windows XP Pro | Windows 2000 |
| Electrical Safety | IEC 60601-1, 2 | IEC 60601-1, 2 |
Table A – Hardware Comparison of CR-Pro to Predicate Devices
2
US 2938
SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE - SOFTWARE (7)
Table B illustrates the comparative equivalence of the CR-Pro to the Predicate device Software.
| Features | eRadlink | OREX | eRadlink² |
|---|---|---|---|
| Product Name | CR-Pro | PcCR | LS-16 |
| 510(k) Number | - | K003256 | K020243 |
| Patient Information - Add/Modify/Delete | Y | Y | Y |
| Fax Report | Y | Y | Y |
| Print Dicom Image | Y | Y | Y |
| Image Rotate and Flip | Y | Y | Y |
| Black/White Inversion | Y | Y | Y |
| Multiple Image Display | Y | Y | Y |
| Dicom Send/Receive/Echo | Y | Y | Y |
| Dicom Query User/Provider | Y | Y | Y |
| Dicom Retrieve User/Provider | Y | Y | Y |
| Dicom Print | Y | Y | Y |
| JPEG Compression lossy/lossless | Y | Y | Y |
| iJPEG Compression | Y | Y | Y |
| Wavelet Compression | Y | Y | Y |
| Industry Standard Digital Communication | |||
| Support | Y | Y | Y |
| Color Images | N | Y | N |
| Cine Loop Viewing | N | Y | N |
| Dicom Removable Media Support | Y | Y | Y |
| Measurement Tools | Y | Y | Y |
| Communication protocols | Y¹ | Y¹ | Y¹ |
Table B - Software Comparison of CR-Pro to Predicate Devices
1 ADSL, Cable and Analog Modems and Phone Lines, ATM, ISDN, FDDL, Ethernet, Token Ring
2 The LaserPro 16 (an earlier product of eRadlink) is cited as a Predicate Device as the application software utilized in that device is the same software used in the CR-Pro with minor start-up; phosphor plate handling and erasing modifications.
3
K052938
| Color Images | N | Y | N |
|---|---|---|---|
| Cine Loop Viewing | N | Y | N |
| Dicom Removable Media Support | Y | Y | Y |
| Measurement Tools | Y | Y | Y |
| Communication protocols | Y1 | Y1 | Y1 |
ADSL, Cable and Analog Modems and Phone Lines, ATM, ISDN, FDDL, Ethernet, Token Ring
2 The LaserPro 16 (an earlier product of eRadlink) is cited as a Predicate Device as the application software utilized in that device is the same software used in the CR-Pro with minor start-up; phosphor plate handling and erasing modifications.
EFFECTIVENESS (8)
Program testing and calibration using Beryllium gray-scale wedge, body part phantoms and typical x-ray plate samples has demonstrated the CR-Pro's conformance to its defined specifications.
SAFETY (9)
The CR-Pro complies with the following standards:
| Standard:year | Name |
|---|---|
| 21CFR1040.10 | PERFORMANCE STANDARDS FOR LIGHT-EMITTING PROD- |
| UCTS: Laser products | |
| DICOM 3:2004 | Digital Imaging and Communications in Medicine (including JPEG |
| coding per section 3.6) | |
| EN55022:1998 includ- | |
| ing A1:2000 | Information technology equipment — Radio disturbance characteris- |
| tics — Limits and methods of measurement | |
| EN55024:1998 includ- | |
| ing A1:2001 and | |
| A2:2003 | Information technology equipment — Immunity characteristics — |
| Limits and methods of measurement | |
| EN61000-3-2:2000 | Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits |
| for harmonic current emissions (equipment input current up to and in- | |
| cluding 16 A per phase) | |
| EN61000-3-3:1995 in- | |
| cluding A1:2001 | Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limita- |
| tion of voltage changes, voltage fluctuations and flicker in public low- | |
| voltage supply systems, for equipment with rated current ≤ 16 A per | |
| phase and not subject to conditional connection | |
| IEC 60601-1:1988 in- | |
| cluding am1:1991 and | |
| am2:1995 | Medical electrical equipment - Part 1: General requirements for safety |
| IEC 60601-1-2 (2001- |
-
| Medical electrical equipment - Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility - Require-
ments and tests |
| SMPTE RP 215-2001 | Encoding Film Transfer Information into Vertical Ancillary Data for
SMPTE 292M Bit-Serial Interface |
| SMPTE 349M-2001 | Television - Transport of Alternate Source Image Formats through
SMPTE 292M |
4
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or bird-like figure with three stylized lines representing its wings or body. The emblem is black, and the text around the perimeter is also in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
eRadlink, Inc. % Mr. Ned Devine Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K052938
NOV 1 7 2005
Trade/Device Name: eRadlink CR-Pro Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB
Dated: November 3, 2005 Received: November 4, 2005
Dear Mr. Devine:
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, listing 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 (Premarket Approval), it may be subject to such 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): 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.
5
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
: 上一篇:
6
Indications for Use 510(k) Number (if known):
Device Name: eRadlink CR-Pro
Indications for Use:
The CR-Pro is a free standing, laser driven, image digitizer intended to produce digital copies of phosphor plate recorded images in 16 levels of gray scale. The digital copies are transmitted to an internal Intel Pentium 4 based personal computer (PC) where they may be displayed, processed, or compressed for archiving or transmission via computer networks to other medical facility sites.
This device is not to be used for primary imaging diagnosis in mammography.
Prescription Use (Part 21 CFR 801 Subpart D)
ADIOR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segarra
(Division Sign-Off) Division of Reproductive, Abdominal, a Radiological Devices 510(k) Number
б
Software Certification Statement